Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.
Interventions for Patients With Alzheimer's Disease and Dysphagia
The overall purpose of this project is to develop effective dysphagia rehabilitative
interventions for patients with Alzheimer's Disease and related dementias at risk for
pneumonia development.
Nicole Rogus-Pulia, PhD
All
50 Years to 99 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03682081
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Inclusion criteria (patients):
• Age 50-99
• English speaking
• Diagnosis of dementia or cognitive impairment or memory loss
• Clinical Dementia Rating (CDR) scale score between 0.5 and 2.0
• Actively involved caregiver
• Resides at home, assisted living facility, or long-term care facility
Inclusion criteria (caregivers)
• English speaking
• Age 18 and older
• Contact with patient at least 1 time a week
• Has access to a working telephone
Exclusion criteria (patients):
• Dementia due to cerebrovascular disease as primary cause
• History of head and neck cancer or other structural deformity that can affect
swallowing
• Allergy to barium
• Currently breastfeed or pregnant or planning to become pregnant
Exclusion criteria (caregivers):
• Lacks ability to give consent
Dementia, Dysphagia, Alzheimer Disease, Alzheimer's disease, Aphagia and dysphagia, Dementia in other diseases classified elsewhere, Mild Cognitive Impairment, Unspecified dementia, Other, Aging & Geriatrics, Food & Nutrition
Fetal research and clinical practice has been hampered by a lack of suitable investigational
techniques. Currently, ultrasound is the only widely used method of studying fetal anatomy
and physiology, but it has significant limitations for assessment of cardiac rhythm. The
proposed study will allow the investigators to evaluate fetal magnetocardiography (fMCG) as a
new tool for the study of normal and abnormal fetal heart rate and rhythm.
Ronald Wakai, PhD
Female
18 Years and over
NA
This study is also accepting healthy volunteers
NCT03047161
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Inclusion Criteria:
• uncomplicated pregnancy at gestational age >12 weeks
• pregnancy complicated by abnormal fetal heart rate or rhythm or risk of abnormal fetal
heart rate or rhythm at gestational age >15 weeks
Exclusion Criteria:
• uncomplicated pregnancy <12 weeks gestation
• pregnancy complicated by abnormal fetal heart rate or rhythm or risk of abnormal fetal
heart rate or rhythm at gestational age <15 weeks
Healthy Volunteers, Supervision of high risk pregnancy, Other, Fetal Arrhythmia
FFNP-PET/MR Imaging of Progesterone Receptor Expression in Invasive Breast Cancer
The goal of this research is to test the accuracy of PET/MRI imaging with
18F-fluorofuranylnorprogesterone (FFNP) for measuring progesterone receptor (PR) expression
in patients with invasive breast cancer. The hypothesis is that FFNP SUVmax from PET/MRI will
correlate well against the semi-quantitative PR immunohistochemistry score.
Amy Fowler, MD, PhD
Female
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT03212170
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Inclusion Criteria:
• Women 18 years of age or older
• Diagnosis of biopsy-proven invasive breast cancer measuring at least 1.0 cm in
diameter by any imaging modality
• Biopsy-proven PR-positive or PR-negative invasive breast cancer
• Undergoing diagnostic breast MRI ordered by the referring clinician for staging and
extent of disease
Exclusion Criteria:
• Inability or unwillingness to provide informed consent to the study
• Participants currently undergoing neoadjuvant chemotherapy/endocrine therapy or those
who have received chemotherapy/endocrine therapy within 6 months prior to the MRI
• Participants who have had neoadjuvant chemotherapy/endocrine therapy, surgical
intervention, or radiation for the current biopsy-proven malignancy
• Participants with breast expanders
• Participants who are or might be pregnant or lactating
• Participants with a contraindication to gadolinium based contrast agents, including
allergy or impaired renal function (per University of Wisconsin Health Guidelines)
• Participants with a history of allergic reaction attributable to compounds of similar
chemical or biologic composition to FFNP
• Participants in liver failure as judged by the patient's physician
• Participants with standard contraindications to MRI, including claustrophobia and
metallic implants incompatible with MRI
• Participants requiring intravenous (IV) conscious sedation for imaging are not
eligible; participants requiring mild, oral anxiolytics for the clinical MRI will be
allowed to participate as long as the following criteria are met:
• The subject has their own prescription for the medication
• The informed consent process is conducted prior to the self-administration of
this medication
• They come to the research visit with a driver
• Participants unable to lie prone for 30 minutes for imaging
FES Imaging to Optimize Tamoxifen for Metastatic Breast Cancer
Despite broad advancements in endocrine therapy for ERα+ breast cancer, resistance ultimately
develops. A common driver of resistance are known ESR1 mutations that lead to constitutively
active receptor signaling and transcriptional regulation that is always "turned on" despite
the absence of estrogen. Patients with ESR1 mutations are expected to have decreased binding
affinity for tamoxifen and thus may be underdosed on standard therapy. [18F]-fluoroestradiol
Positron Emission Tomography/Computed tomography (FES-PET/CT) imaging is a novel functional
imaging technique that can non-invasively measure ERα expression and inhibition in metastatic
ERα+ breast cancer. The proposed a pilot study uses FES-PET/CT imaging to measure ERα
blockade to determine the optimal dose of tamoxifen in patients with ESR1 mutations.
Kari Wisinski, MD
All
19 Years and over
Early Phase 1
This study is NOT accepting healthy volunteers
NCT04174352
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Inclusion Criteria:
• Participants must have histologically confirmed breast cancer that is metastatic or
unresectable with the following:
• Estrogen receptor expression by immunohistochemistry greater than or equal to 10%
• ESR1 mutation identified using a Clinical Laboratory Improvement Amendments
(CLIA) certified assay via tumor biopsy tissue or circulating free DNA (cfDNA)
• human epidermal growth factor receptor 2 (HER2) negative
• Participants must have measurable disease as defined by RECIST 1.1 or evaluable bone
disease with at least one lesion measuring 10 mm or greater in size. (Participants
with bone and non-bone disease are eligible. One disease site must meet either the
measurable or evaluable criteria outlined.) Participants with liver-only disease are
not eligible due to the inherent hepatic uptake related to the radiopharmaceutical's
hepatobiliary route of elimination.
• Participants must have received at least 1 prior line of endocrine therapy in the
metastatic setting or have had progression within 12 months of adjuvant endocrine
therapy. Prior Tamoxifen is allowed in any setting. Prior CDK4/6 in the metastatic
setting per NCCN guidelines is allowed.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (See Appendix A)
• Life expectancy of greater than 12 weeks.
• Ability to take oral medications.
• Informed consent: participant must be informed of the investigational nature of the
study and must be able to sign a written informed consent.
• Participants with central nervous system (CNS) metastases must be stable after therapy
for CNS metastases (such as surgery, radiation, or stereotactic radiosurgery) for at
least 1 month.
• Participants must have adequate normal organ and bone marrow function as defined
below:
• Absolute neutrophil count >/= 1,000/mcL
• Hemoglobin >/= 9.0 g/dL
• Platelets >/= 100,000/mcL
• Total bilirubin = 1.5 x upper limit of normal (ULN)
• AST (SGOT)/ ALT (SGPT) = 2.5 x ULN; = 5 x ULN in the setting of metastatic
liver disease
• Creatinine = 1.5 x ULN or creatinine clearance >/= 50 mL/min
Exclusion Criteria:
• Prior chemotherapy, radiotherapy, targeted, immunotherapy or investigational therapy
within 2 weeks or major surgery within 4 weeks of study enrollment or those who have
not recovered (to grade ≤ 1 or baseline) from clinically significant adverse events
due to agents administered more than 2 weeks earlier (alopecia and fatigue excluded).
• Participants must not be receiving an ER blocking endocrine therapy (includes
fulvestrant, tamoxifen, toremifene, raloxifene) and must be off the agents for a
minimum of 60 days prior to planned FES PET/CT to allow for adequate uptake of FES.
• History of allergic reactions attributed to compounds of chemical or biologic
composition similar to those of tamoxifen or [18F]-fluoroestradiol.
• Peripheral neuropathy of severity greater than grade 1.
• Current optic nerve disorders, retinopathy, lattice degeneration, macular
degeneration, retinal vascular disorder, or retinal tears of severity greater than
grade 1.
• History of cerebellar disorders, ataxia, and uncontrolled seizures unless related to
transient medical condition and in investigator's opinion is not an active medical
issue.
• History of venous thrombosis/thromboembolic event, including pulmonary embolism and
stroke.
• Have a heart-rate corrected QT interval (using Fridericia's formula) (QTcF) ≥ 470msec
or other factors that increase the risk of QT prolongation or arrhythmic events (e.g.,
heart failure, chronic hypokalemia, family history of long QT interval syndrome).
• Are taking medications that are known to prolong the QT interval, unless they can be
transferred to other medications ≥ 5 half-lives prior to dosing or unless the
medications can be properly monitored during the study. If equivalent medication is
not available, QTcF should be closely monitored.
• Tamoxifen has demonstrated vaginal bleeding, birth defects and fetal loss in pregnant
women. Tamoxifen use during pregnancy may have a potential long-term risk to the fetus
of a Diethylstilbestrol syndrome (DES)-like syndrome. Women of childbearing potential
(WOCP) must not be pregnant (confirmed by a negative urine/serum pregnancy test within
14 days of tamoxifen treatment). In addition, a medically acceptable method of birth
control must be used such as an intrauterine device (IUD), use of a double barrier
method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or
cream), or total abstinence during the study participation and for 3 months after last
dose of study drug. Women who are postmenopausal for at least 1 year or surgically
sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) are not
considered to be WOCP.
• Ongoing treatment with other investigational agents. Participants cannot be receiving
concomitant chemotherapy, radiotherapy, experimental therapy or any other therapy not
otherwise outlined by the trial for the purposes of anti-cancer treatment.
• History of uterine malignancy unless participant has had hysterectomy with no evidence
recurrent disease for ≥ 3 years from definitive therapy.
• Concurrent malignancy except for the following:
• Basal cell or squamous cell skin cancer
• In situ cervical cancer
• The following medications are contraindicated or must be used with caution.
• Contraindicated:
• CYP2D6, CYP3A4, and CYP2C9 strong inhibitors
• CYP2D6, CYP3A4, and CYP2C9 strong inducers
• Use with caution:
• CYP2C9 sensitive substrates
• CYP2D6 moderate inhibitors or inducers
• CYP3A4 moderate inhibitors or inducers
Note: Transdermal products designed for systemic delivery must be assessed for interaction
potential. Topical products not designed to provide systemic delivery (including inhaled
products, ophthalmologic products and transvaginal preparations) do not need to be
considered.
Contraindicated medications are not allowed. Participants taking these concurrent
medications are ineligible unless they can discontinue or switch to alternative medications
prior to initiation of study drug (at least 5 half-lives).
Use with caution agents are permitted if a) discontinuation is not feasible or b) no
acceptable alternatives are available as determined by the treating physician; however,
caution should be used. Consider monitoring by symptoms, labs or drug levels and dose
adjustments of the medication.
• Uncontrolled intercurrent clinically significant illness including, but not limited
to, ongoing or active infection, symptomatic congestive heart failure, unstable angina
pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would
limit compliance with study requirements.
Adjunctive Effects of Psilocybin and a Formulation of Buprenorphine
Primary Aim: In participants with OUD, to characterize adverse events associated with adding
two psilocybin doses to a stable buprenorphine-naloxone formulation.
Secondary Aim: To evaluate the effect of psilocybin treatment on the effectiveness of a
buprenorphine-naloxone maintenance therapy.
Secondary Aim: To evaluate the effect of concurrent buprenorphine-naloxone use on the effects
of psilocybin therapy.
Descriptive Aim: To describe any changes in self-efficacy, quality of life, pain.
Randall Brown, MD
All
21 Years to 65 Years old
Phase 1
This study is NOT accepting healthy volunteers
NCT04161066
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Inclusion Criteria:
• Aged 21 to 65 years
• Able to read, speak, and understand spoken and written English
• Diagnosis of moderate or severe opioid use disorder (OUD)
• Current opioid misuse, with misuse occurring on at least 10 of the last 30 days.
Misuse will be defined as either:
1. Use of illicit opioids, such as heroin or non-prescribed fentanyl; or use of an
outpatient prescription opioid (such as oxycodone, morphine, or hydrocodone)
through a route other than FDA approved (e.g. nasal, injected), and/or
2. Use of a prescription opioid via a route (e.g. nasal, injected, chewed) or for a
purpose (e.g. intoxication, anxiety relief) other than that for which it was
prescribed.
• Able to achieve stable daily dose of a buprenorphine-naloxone formulation that
controls opioid withdrawal symptoms
• Persons of childbearing potential must agree to practice an effective means of
contraception throughout their participation in the study, beginning at screening and
throughout follow-up
• Ability and willingness to adhere to study requirements, including attending all study
visits, preparatory and follow-up sessions, and evaluations
• Healthy kidney function
• Able to provide contact information for a local support person. This person must be
available during both 24-hour treatment and observation periods, and willing to
provide the participant social/emotional support the day after each treatment and as
needed during the dosing day and/or overnight observation period.
Exclusion Criteria:
• Currently prescribed and has taken buprenorphine or buprenorphine formulation (e.g.,
Suboxone®) for over four weeks immediately prior to initial study contact
• Currently receiving pharmacotherapy of any duration with methadone
• Current participation in a drug treatment court program or other legal supervision.
Individuals who are under legal supervision will be advised that participating in this
study could potentially violate terms of probation, parole, or extended supervision.
Contact information for the individual's community supervision officer must be
collected to confirm whether study participation may impact the potential
participant's status on probation or parole
• Inadequately treated hypertension
• Current acute coronary syndrome or angina
• Evidence of ischemic disease, cardiac conduction defects, and/or ventricular
arrhythmias on screening ECG
• History of heart transplant
• Current insulin dependence, due to Type I or Type II diabetes
• Urine drug test containing non-prescribed drugs of abuse
• Any finding(s), based on the screening process, that the PI feels makes the study
unsuitable for the participant
Opioid Use Disorder, Opioid abuse, Other, Addiction & Substance Abuse
Stroke Rehabilitation Using Brain-Computer Interface (BCI) Technology
The purpose of this research is to determine if functional muscle stimulation, directed by
electroencephalogram (EEG) output, can increase the extent of stroke recovery on behavioral
measures and induce brain plasticity as measured by functional magnetic resonance imaging
(fMRI). Participants will include stroke patients with upper-limb hemiparesis and can expect
to be on study for approximately 4 months.
Vivek Prabhakaran
All
50 Years to 85 Years old
N/A
This study is also accepting healthy volunteers
NCT04141774
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Inclusion Criteria:
• New-onset ischemic stroke 12 months prior •chronic time frame;
• Right hand dominant •affected arm;
• Mild to moderate unilateral upper extremity impairment or severe unilateral upper
extremity impairment;
• No upper extremity injury or conditions that limited use prior to the stroke;
• Must be able to provide informed consent on their own behalf.
Exclusion Criteria:
• Inability to competently participate in study procedures
• Concurrent upper extremity therapy, other neurological or psychiatric disorders
Stroke, Transient cerebral ischemic attacks and related syndromes, Other
Use of High-resolution Manometry to Detect Upper Airway Obstruction During Sleep
Obstructive sleep apnea (OSA) is a major public health issue in both children and adults,
present in 1-5% of children and 10-30% of adults. It is characterized by repeated episodes of
airway obstruction during sleep, leading to brain arousal, sympathetic activation, oxygen
desaturation, sleep fragmentation, and non-restorative sleep. Patients report daytime
tiredness, insomnia, and morning headaches. Children with OSA experience daytime somnolence,
difficulties at school, behavioral problems, enuresis, and reduced quality of life. If left
untreated, OSA can lead to numerous complications including hypertension, cardiovascular
disease, stroke, and insulin resistance. Sleep partners are also affected, with patients
viewing their disorder as a burden and sleeping in separate rooms. Further, disease
prevalence is increasing as obesity increases.
Continuous positive airway pressure (CPAP) is the current gold standard treatment for OSA. If
used effectively and consistently, it can improve patient symptoms. However, adherence is
generally poor, with patients experiencing physical discomfort, chest discomfort, and dry
mouth. For those patients that cannot tolerate CPAP, surgical intervention is an option. In
children, this typically starts with adenotonsillectomy. However, 20-75% of children will
have persistent symptoms after adenotonsillectomy. In adults, anatomic factors including
tonsil hypertrophy and redundant pharyngeal tissue can contribute to upper airway obstruction
and may also necessitate higher pressures for effective CPAP treatment. Even if surgical
intervention does not cure the OSA, it may make CPAP more tolerable and improve CPAP
adherence.
Sleep-related airway obstruction is a complex phenomenon potentially involving multiple
anatomic levels. For patients with persistent symptoms despite initial therapy or intolerance
to CPAP, further evaluation of the upper airway is clinically valuable. Polysomnography (PSG)
is the gold standard for diagnosing OSA, but it does not provide information on the
location(s) of upper airway obstruction. Knowledge of the precise sites of obstruction is
critical to planning effective sleep surgery. Currently, this is accomplished with
drug-induced sleep endoscopy (DISE). DISE was originally proposed in 1991 and involves
administering anesthetic to a patient to simulate a sleep state, and then visualizing the
upper airway using transnasal flexible endoscopy. Sites of obstruction at key locations
including the adenoids, soft palate, lateral oropharynx, tongue base, and epiglottis can be
identified.
Though DISE offers valuable clinical information, it has notable limitations. First, it
cannot evaluate the entire upper airway simultaneously, as any obstruction occurring
superiorly precludes visualization of any obstruction occurring more inferiorly. Second,
interpretation of DISE is subjective and there is no universally accepted system for
analysis. Rating systems are qualitative, using grades such as complete, partial, or no
obstruction as opposed to quantitative measurements.
The optimal sleep assessment would be quantitative, reliable, and provide information on the
entire upper airway simultaneously. A potential alternative to DISE which could meet these
criteria is sleep manometry. Measurement of upper airway pressures captures the effects of
obstruction along the entire upper airway, from the nasopharynx to larynx. Prior studies have
attempted to employ manometry, but have been limited primarily by inadequate equipment and
suboptimal methods of data analysis. Woodson et al. used a solid-state manometer with
diameter of 2.3 mm and 5 sensors to detect palatal obstruction and tongue base obstruction in
patients with OSA. They also used the same approach to detect persistent tongue base
obstruction following uvulopalatopharyngoplasty. While these studies help demonstrate that
manometry can be a useful adjunct to OSA assessment, they are severely limited both by the
type of manometer used as well as the lack of a clear, detailed description of the method of
data analysis.
High-resolution manometry (HRM) uses pressure censors spaced 1 cm apart to allow for pressure
measurement along the entire upper airway. The investigators have previously applied HRM to
assessment of swallow physiology. Sophisticated methods of automated data analysis have been
developed that have been shown to be reliable for both expert and novice users . Further,
pattern recognition techniques have been applied to identify dysphagia and specific
swallowing abnormalities. Application of this technology and modification of existing data
analysis platforms will allow for a quantitative, reliable, and comprehensive assessment of
upper airway obstruction during sleep in both children and adults, with potential for
development of algorithms to predict effects of targeted surgical therapy at all levels of
the upper airway.
Timothy Mcculloch, MD
All
5 Years to 90 Years old
NA
This study is also accepting healthy volunteers
NCT04139499
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Inclusion Criteria:
ADULTS
• Age 18-90
• Any participant undergoing sleep endoscopy as part of standard clinical care would be
eligible. This entails physician concern for sleep-disordered breathing and
corresponding questionnaire and/or polysomnogram results supporting a diagnosis of
obstructive sleep apnea.
• Participants without apnea are eligible, provided they are undergoing tonsillectomy or
bronchoscopy for either chronic tonsillitis or airway assessment without concern for
history of sleep apnea.
• Women with childbearing potential will not be excluded, as the proposed experiment
would have no potential ramifications on childbearing potential.
CHILDREN
• Age 5-17
• Any patients undergoing sleep endoscopy as part of standard clinical care would be
eligible.
• Participants undergoing either tonsillectomy for chronic tonsillitis or bronchoscopy
for airway assessment.
• Women with childbearing potential will not be excluded, as the proposed experiment
would have no potential ramifications on childbearing potential.
Exclusion Criteria:
• Participant desire to avoid added anesthesia time.
• Inability to safely tolerate the added anesthesia time (about 5-10 minutes) for the
experiment (as judged by either otolaryngologist or anesthesiologist).
• Pregnant women
• Vulnerable groups (i.e., prisoners, individuals lacking consent capacity, individuals
unable to read the consent form).
Acute obstructive laryngitis [croup] and epiglottitis, Other, Obstructive Sleep Apnea
Oropharyngeal dysphagia, or difficulty swallowing, is a devastating condition that affects
physiological and psychosocial functioning in 1 in 25 adults. Many dysphagia treatments
exist, but our ability to adequately measure treatment outcomes is limited. Pharyngeal
high-resolution manometry (pHRM) directly measures swallowing pressures, providing an
objective measurement of physiology that characterizes the basic mechanisms of swallowing.
pHRM is well-poised to measure outcomes of dysphagia treatments due to its direct, objective,
and reproducible measures of swallowing function.
This proposed project will address a central hypotheses that objective swallowing measures
(including (pHRM) will reveal treatment-mediated swallowing changes, will align with
patient-reported outcome measures, and will be able to predict who will benefit from
treatment. The investigators will follow a cohort of participants with oropharyngeal
dysphagia as they undergo either pharyngeal strengthening therapy or relief of upper
esophageal sphincter outlet obstruction at three time points: baseline, mid-treatment (4-6
weeks) and post-treatment (10-12 weeks). The investigators will compare participants to
healthy controls using pHRM, videofluoroscopy, diet assessment, functional reserve tests, and
patient-reported outcome measures.
Timothy Mcculloch, MD
All
18 Years to 99 Years old
NA
This study is also accepting healthy volunteers
NCT04130867
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Inclusion Criteria:
• Pathological Group
• Must have dysphagia as diagnosed by a licensed and certified otolaryngologist,
gastroenterologist, or speech-language pathologist AND must have a dysphagia
treatment plan that includes one of the following primary goals:
• Therapy to strengthen oropharyngeal musculature
• Medical or surgical management to relieve an obstruction at the upper
esophageal sphincter
• Must agree to comply with swallowing assessment, including interview and
manometry
• Must sign the Informed Consent form approved by the Health Sciences Institutional
Review Board of the University of Wisconsin
• Normal Group
• Having no swallowing disorders
• Must agree to comply with swallowing assessment, including interview and
manometry
• Must sign the Informed Consent form approved by the Health Sciences Institutional
Review Board of the University of Wisconsin.\
Exclusion Criteria:
• Pathological Group
• Therapeutic management plan already initiated prior to recruitment
• Therapy goals including only improvement of swallowing coordination
• Developmental disability, dementia, cognitive dysfunction, or difficulty
comprehending instructions
• Positive history of allergic response to topical anesthetic
• Allergy to food relevant to study participation (e.g. lactose intolerance)
• Normal Group
• Known swallowing disorder
• Developmental disability, dementia, cognitive dysfunction, or difficulty
comprehending instructions
• Positive history of allergic response to topical anesthetic
• Allergy to food relevant to study participation (e.g. lactose intolerance)
This is a Phase II/III, Single-center, Prospective, Open-label, Single Arm Study of 30
Simultaneous Kidney Pancreas recipients who received a transplant at least 3 months, but no
more than 5 years prior, with a history of tremors following transplantation.
Jon Odorico, MD
All
18 Years to 70 Years old
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT03769298
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Inclusion Criteria:
• Adult, 18-70 years of age
• Participant must be able to understand and provide consent
• History of Diabetes Type 1 or Insulin-Dependent Diabetes Type 2 with Chronic Kidney
Disease (CKD)
• Recipient of a Simultaneous Pancreas Kidney (SPK) transplant, 3- 60 months prior to
screening, per Principal Investigator's discretion.
• Have a history of tremors following transplantation
• Stable pancreas allograft function as evidenced by no requirement of exogenous insulin
or oral anti-diabetic agents and stable pancreatic enzymes
• Stable kidney allograft function
• Currently taking Immediate-Release (IR) tacrolimus
• Women of child-bearing potential (WOCP) must have a negative pregnancy test at the
time of study entry
Exclusion Criteria:
• Currently maintained on an extended-release tacrolimus immunosuppressive regimen
• Previous history of tremors prior to transplantation
• Solitary pancreas transplant recipients
• History of solid organ transplant other than a kidney or pancreas
• Uncontrolled concomitant infection at the discretion of the investigator
• Presence of Donor Specific Antibodies
A Closed Loop Neural Activity Triggered Stroke Rehabilitation Device
The purpose of this research is to determine if two non-invasive brain stimulation
techniques, muscle stimulation of the arm and neuro-stimulation through the tongue, can
increase the extent of stroke recovery.
Vivek Prabhakaran
All
18 Years and over
N/A
This study is also accepting healthy volunteers
NCT02098265
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Inclusion Criteria (Experimental Group):
• Stroke patients with persistent upper extremity (UE) deficits
Inclusion Criteria (Control Group 1)
• Stroke patients without UE impairments
• Participants with risk factors for stroke
• healthy controls
• No known neurologic, psychiatric or developmental disability
Inclusion Criteria (Control Group 2)
• Stroke patients with persistent upper extremity (UE) deficits
• Moderate upper extremity (dominant right hand affected) impairment (score of 1 or 2 on
the motor sub-component of the NIH stroke scale (NIHSS) and ARAT score 20-45)
• No upper extremity injury or conditions that limited use prior to the stroke
• Pre-stroke independence with a Modified Rankin Score of 0 or 1, for the standard FES
only intervention.
Exclusion Criteria (for all participants):
• Allergic to electrode gel, surgical tape and metals
• Participants under treatment for infectious diseases or having apparent oral lesions
or inflammation will be excluded from the study
• Women who are pregnant or may become pregnant during the course of the study will be
excluded
• Participants with contraindications for MRI will be offered the opportunity to
participate in the interventions study only (e.g. EEG-BCI-FES and behavioral testing)
Exclusion Criteria (for healthy controls)
• Contraindications for MRI
• Allergic to electrode gel, surgical tape, and metals.
Oxaliplatin and Liposomal Irinotecan (Plus Trastuzumab for HER2-positive Disease) in Advanced Esophageal and Gastric Adenocarcinoma
This is an open label, phase II, multi-site trial evaluating the efficacy and safety of the
combination of 5-FU, oxaliplatin, nal-IRI, and immunotherapy (plus trastuzumab for
HER2-positive tumors) as first-line therapy for participants with advanced Esophageal and
Gastric Adenocarcinoma (EGA). The investigators hypothesize that this drug combination will
be better tolerated than current first-line chemotherapy combinations for this disease.
Nataliya Uboha, MD
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT04150640
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Inclusion Criteria:
• Written informed consent and HIPAA authorization for release of personal health
information.
NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
• Histological or cytological confirmed locally advanced or metastatic EGA. Known HER2
status prior to treatment initiation required. Known PDL1 CPS status prior to
treatment initiation.
• Measurable disease according to RECIST v1.1.
• No prior lines of systemic therapy for advanced disease.
• Participants who had received neoadjuvant or adjuvant therapy or definitive
chemoradiation will be allowed to participate if recurrence occurred 6 months or
longer from the completion of all prior treatments.
• Demonstrate adequate organ function as defined below; all screening labs to be
obtained within 14 days prior to registration
• Absolute Neutrophil Count (ANC) ≥1,500 /μl without the use of hematopoietic
growth factors
• Hemoglobin (Hgb) ≥8 g/dL (blood transfusions are permitted for participants with
hemoglobin levels below 8 g/dL)
• Platelets ≥100,000 /μl
• Serum creatinine ≤1.5 X upper limit of normal (ULN) OR Measured or calculated
creatinine clearance (GFR can also be used in place of creatinine or CrCl). CrCl
calculation using the Cockcroft-Gault formula. ≥50 mL/min for participants with
creatinine levels > 1.5 X institutional ULN
• Bilirubin within normal range for the institution (biliary drainage is allowed
for biliary obstruction)
• Aspartate aminotransferase (AST) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver
metastases
• Alanine aminotransferase (ALT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver
metastases
• Albumin >3.0 g/dL
• International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless
subject is receiving anticoagulant therapy as long as PT or PTT is within
therapeutic range of intended use of anticoagulants
• Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is
receiving anticoagulant therapy as long as PT or PTT is within therapeutic range
of intended use of anticoagulants
• Women of childbearing potential should have a negative urine or serum pregnancy test
within 14 days of study registration. NOTE: Women are considered of child bearing
potential unless they are surgically sterile (have undergone a hysterectomy, bilateral
tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at
least 12 consecutive months
• Women of childbearing potential and males must be willing to abstain from heterosexual
activity or to use a form of effective method of contraception from the time of
informed consent until 30 days after treatment discontinuation.
• As determined by the enrolling physician or protocol designee, ability of the subject
to understand and comply with study procedures for the entire length of the study.
Exclusion Criteria:
• Known hypersensitivity to 5-FU, oxaliplatin or other platinum agents, or any of the
components of nal-IRI and other liposomal products.
• Known dihydropyrimidine dehydrogenase (DPD) deficiency (testing not required prior to
enrollment).
• Other active malignancy requiring treatment within the last 2 years. Exceptions
include subjects with non-melanoma skin cancer, non-invasive/in situ cancer or
low-risk prostate cancer requiring hormonal therapy only.
• Current therapy with other investigational agents or participation in another clinical
study (supportive care and nontherapeutic trial participation allowed if not receiving
an investigational drug). Participants may participate in prescreening for other
therapeutic trials (prescreening of biologic sample for specific mutations, receptors,
etc.)
• Major surgery within 28 days or minor surgery within 14 days of the start of the study
treatment, except for tumor biopsy or placement of central infusion device (port
placement).
• Radiotherapy less than 7 days prior to the start of the study treatment
• Participants who receive nivolumab or pembrolizumab in addition to chemotherapy should
not have any contraindications to immune checkpoint inhibitors and should not have
received immunotherapy agents for the treatment of EGA prior to study enrollment.
• Participants must not have active autoimmune disease that has required systemic
treatment in the past 2 years. Participants are permitted to receive
immunotherapy l if they have vitiligo, type I diabetes mellitus, residual
hypothyroidism due to autoimmune condition only requiring hormone replacement,
psoriasis not requiring systemic treatment, or conditions not expected to recur
in the absence of an external trigger (precipitating event).
• Participants must not have a condition requiring systemic treatment with either
corticosteroids (>10 mg/day prednisone equivalents) or other immunosuppressive
medications within 14 days of study immunotherapy administration. Inhaled or
topical steroids and adrenal replacement doses (≤10 mg/day prednisone equivalent)
are permitted. Participants with prior immune mediated adverse events related to
immunotherapy that resulted in permanent treatment discontinuation with these
agents.
• Psychological, familial, or sociological condition potentially hampering compliance
with the study protocol and follow-up schedule.
• Active infection requiring systemic therapy.
• Pregnant or breastfeeding.
• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Participants with previously treated brain metastases may participate provided they
are stable (without evidence of progression by imaging for at least four weeks prior
to the first dose of trial treatment and any neurologic symptoms have returned to
baseline), have no evidence of new or enlarging brain metastases, and are not using
steroids for at least 7 days prior to trial treatment. This exception does not include
carcinomatous meningitis, which is excluded regardless of clinical stability.
• Severe arterial thromboembolic events (myocardial infarction, unstable angina
pectoris, stroke) less than 6 months before inclusion.
• NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled
blood pressure.
• Known history of Human Immunodeficiency Virus (HIV).
This study is investigating a new administration schedule of Rituximab, Cyclophosphamide,
Doxorubicin, Vincristine, Prednisone (R-CHOP) chemotherapy for participants with Diffuse
Large B-Cell Lymphoma (DLBCL), focusing on an underserved elderly population (aged 75 and up;
certain participants 70-74 may be eligible) that is often excluded from clinical trials.
Participants can expect to be on study for 2.5 years (treatment for 6 months and 2 years of
post treatment follow-up).
Christopher Fletcher, MD
All
70 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT03943901
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Inclusion Criteria:
• Signed and dated informed consent document indicating that the participant (or legally
acceptable representative) has been informed of all pertinent aspects of the trial
• All patients age ≥75 years and participants aged 70-74 years who are determined to be
unfit or frail by Cumulative Illness Rating Score-Geriatrics (CIRS-G) scale
• For participants aged 70-74 years: CIRS-G score with 5-8 comorbid conditions
scored 2 or ≥1 comorbidity scored 3-4. CIRS-G score is to be reviewed by the
study PI prior to enrollment.
• Newly diagnosed, untreated, biopsy proven CD20 positive DLBCL (including high grade
B-cell lymphoma & T-cell/histiocytic rich large B-cell lymphoma). Participants with
discordant bone marrow (i.e. involved by low-grade/indolent NHL) are eligible.
Participants with transformed DLBCL from underlying low-grade disease are eligible.
Participants with composite DLBCL and concurrent low-grade lymphoma are eligible.
• Copy of pathology report must be sent to coordinating site to confirm diagnosis
for eligibility
• Participants with prior treatment for low grade NHL with non-anthracycline based
regimens are eligible
• Measurable disease by PET/CT or Bone Marrow (BM) biopsy prior to enrollment
• Left ventricular ejection fraction ≥50% by resting echocardiography or resting
Multi-gated acquisition (MUGA) scan
• Karnofsky Performance Score ≥50
• Ann Arbor Stage II bulky, III, or IV disease
• Minimum life expectancy greater than 3 months
• Negative HIV test
• For participants with hepatitis B virus antigen (HbsAg) or core antibody (HbcAb)
seropositivity, participants must have a negative Hep B viral load and an appropriate
prophylaxis plan must be in place during chemotherapy therapy treatment. For all
participants that have Hep B core antibody positive, they should take entecavir
prophylaxis (0.5 mg PO daily) until 1 year from completion of chemotherapy. Hep B
viral load should be checked on these participants prior to starting chemotherapy and
every 3 months thereafter if initial Hep B viral load is negative (+/- 1 week if
chemotherapy cycle is delayed). If Hep B viral load is positive, Hepatology or
Identification (ID) referral is recommended, and hepatitis B virus (HBV) viral load
should be checked monthly
• For participants with hepatitis C Ab (HbcAb) positivity, a viral load must be checked
and be negative for enrollment
• Intrathecal chemotherapy for central nervous system prophylaxis only can be given at
the discretion of the primary oncologist
Exclusion Criteria:
• History of previous anthracycline exposure
• Central Nervous System (CNS) or meningeal involvement at diagnosis
• Creatinine Clearance <25 mL/min by body surface area (BSA)-adjusted Cockroft-Gault
• Poor hepatic function, defined as total bilirubin concentration greater than 3.0 mg/dL
or transaminases over 4 times the maximum normal concentration, unless these
abnormalities are felt to be related to the lymphoma.
• Pulmonary dysfunction defined as >2 L of oxygen required by nasal cannula to maintain
peripheral capillary oxygen saturation (SpO2) ≥90% unless felt to be related to
underlying lymphoma.
• Myocardial Infarction within 6 months of enrollment
• Active, uncontrolled infectious disease
• Known concurrent bone marrow malignancies (e.g. myelodysplastic syndrome) or poor
bone-marrow reserve, defined as neutrophil count less than 1.5×10⁹/L or platelet count
less than 100×10⁹/L, unless caused by bone-marrow infiltration with lymphoma
• History of a second concurrent active malignancy or prior malignancy which required
chemotherapy treatment within the preceding 2 years
• Treatment with any investigational drug within 30 days before the planned first cycle
of chemotherapy
• Unable or unwilling to sign consent
Non-Hodgkin's Lymphoma, Lymphoma, Diffuse Large B Cell Lymphoma, DLBCL, Cancer
Immunonutrition and Carbohydrate Loading Strategies in Breast Reconstruction
This study is designed to test the following hypothesis: patients undergoing immediate
alloplastic and autologous breast reconstruction following mastectomy that receive
preoperative immunonutrition will experience a reduction in wound complications in the 30-day
postoperative period compared to a standard of care control group (retrospective chart
review) of 264 (132 alloplastic + 132 autologous) consecutive breast reconstruction patients
prior to 5/25/2018.
Katherine Gast
Female
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03764943
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Inclusion Criteria:
• Medically cleared to undergo oncologic resection and breast reconstructive surgery
(including associated anesthesia) at the University of Wisconsin Hospital
• Undergoing unilateral or bilateral immediate alloplastic or autologous breast
reconstruction by Drs. Afifi, Garland, Gast, Michelotti, Poore, Rao, or Siebert
Exclusion Criteria:
• Pregnant or breast-feeding women
• Incarcerated women
• Males
• Individuals unable to give consent due to another condition such as impaired
decision-making capacity
• Women with intolerance or allergy to any ingredients contained within the Impact
Advanced Recovery formula that prevents safe consumption of this product.
• Impact Advanced Recovery is suitable for lactose intolerance, gluten-free,
kosher, and halal diets.
• We will exclude individuals with galactosemia
• Women who are unable to take oral nutritional supplements
Breast, Wound Complication, Wound Heal, Complications Wound, Surgical Wound Infection, Surgical Site Infection, Breast Cancer, Mastectomy, Lymphedema
Treatment of Cytomegalovirus (CMV) Infections With Viral-Specific T Cells
The present trial will consist of the treatment of 20 pediatric and adult Hematopoietic Stem
Cell Transplantation (HSCT) recipients or immunocompromised participants diagnosed with
opportunistic Cytomegalovirus (CMV) infections with virus-specific, antigen-selected T-cells.
CMV-specific T-cells will be isolated from donor leukapheresis products using the CliniMACS®
Prodigy. Prior studies on transfer of CMV specific T-cells have been shown to be safe and
efficacious in the treatment of CMV infections.
The main trial objective is to evaluate the feasibility and safety of CMV-specific T-cell
transfer in adult and pediatric participants suffering from CMV infections or reactivation
following HSCT or due to other immunocompromised states (e.g.; primary immunodeficiency,
cytotoxic therapy).
Participants will be followed for one year.
Kenneth Desantes, M.D.
All
1 Month and over
Phase 1
This study is NOT accepting healthy volunteers
NCT03798301
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Inclusion Criteria:
1. Adult or pediatric patient suffering from CMV reactivation/infections following HSCT
or due to other immunocompromised states (e.g.; primary immunodeficiency, cytotoxic
therapy).
• CMV reactivation/viremia defined as positive (>500 copies/ml) CMV qPCR and/or
• Presence of symptoms secondary to CMV infection or evidence of invasive CMV
infection (e.g. pneumonitis, colitis) AND
• Patients must have ONE OF THE FOLLOWING CRITERIA:
• Absence of an improvement of viral load after ≥ 14 days of antiviral therapy
with ganciclovir, valganciclovir or foscarnet (decrease by at least 1 log,
i.e. 10-fold), or
• New, persistent and/or worsening CMV-related symptoms, signs and/or markers
of end organ compromise while on antiviral therapy with ganciclovir,
valganciclovir or foscarnet, or
• Have contraindications or experience adverse effects of antiviral therapy
with ganciclovir, valganciclovir or foscarnet, or
• Known resistance to ganciclovir and/or foscarnet based on molecular testing.
2. Recipients of an allogeneic HSCT must be 28 days after stem cell infusion at the time
of T-cell transfer.
3. Written informed consent given by patient or legal representative.
4. Minimum patient age 1 month.
5. Minimum weight 7 lbs.
6. Female patients of childbearing age with negative pregnancy tests.
7. Patient Karnofsky/Lansky Performance Status >30%.
8. Donor eligible based on FACT infectious screening requirements.
Exclusion Criteria:
1. Patient with acute GVHD > grade 2 or active moderate or severe chronic GVHD at time of
T-cell transfer
2. Patient receiving steroids (>1.0 mg/kg body weight (BW) prednisone equivalent) at the
time of T-cell transfer
3. Patient received allogeneic HSCT less than 28 days prior to T-cell transfer
4. Patient treated with donor lymphocyte infusion (DLI) within 28 days prior to T-cell
transfer
5. Patient treated with Thymoglobulin (ATG), Alemtuzumab or T-cell immunosuppressive
monoclonal antibodies within 28 days.
6. Patient with organ dysfunction or failure as determined by Karnofsky (patients >16
years) or Lansky (patients ≤16 years) score ≤30% (Appendix 5)
7. Patients with CMV retinitis
8. Concomitant enrollment in another clinical trial with endpoints interfering with this
study
9. Any medical condition which could compromise participation in the study according to
the investigator's assessment
10. Known HIV infection
11. Female patient who is pregnant or breast-feeding, or adult of reproductive potential
not willing to use an effective method of birth control during study treatment. Note:
Women of childbearing potential must have a negative serum pregnancy test at study
entry.
12. Patients unwilling or unable to comply with the protocol or unable to give informed
consent.
Donor Eligibility:
The original donor will be the first choice as source of T cells. If the original donor is
not available for donation (such as NMDP donor, cord blood unit, or related donor not
available) of peripheral mononuclear cells or does not meet all donor eligibility criteria
(including donor selection criteria based on University of Wisconsin •Madison Standard
Operating Procedures for the selection of allogeneic donors), alternative related donors
will be selected, with preference for those who have full HLA matching in 6/6 loci over
those with partial HLA matching (≥ 3/6 HLA loci).
1. All donors must be ≥ 18 years old, available, CMV IgG positive, eligible and capable
of undergoing a single standard 2 blood volume leukapheresis. If original HSCT donor
is not available, CMV IgG negative or ineligible, a CMV IgG positive fully matched or
haploidentical family donor will be used.
2. Related donors must be at least partially HLA compatible, matching with recipient in
at least 3/6 HLA loci (HLA-A, HLA-B and HLA-DRB1 will be considered for this).
3. Donors must be CMV IgG seropositive.
4. Donors must show CMV T-cell activation after incubation with MACS GMP PepTivator
Peptide Pools of CMV pp65 before undergoing leukapheresis.
5. Donor must meet the criteria for donor selection defined in the Standard Operating
Procedures of the University of Wisconsin Hospitals and Clinics Stem Cell Transplant
Program and in FACT standards.
Pharmacodynamic Biomarkers of Standard Anti-microtubule Drugs as Assessed by Early Tumor Biopsy
Eligible subjects will be assigned to study treatment arms by their treating oncologist,
rather than by the study. The drug, dose, and schedule of administration will be determined
by the treating physician per NCCN guidelines for standard of care chemotherapy regimens for
recurrent or metastatic breast cancer. Study treatment arms include: Taxane (nab-paclitaxel
or paclitaxel), Eribulin, Vinorelbine, Ixabepilone, or the control arm (non-microtubule
targeted chemotherapies such as doxorubicin, carboplatin, or gemcitabine).
Mark Burkard, MD, PhD
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03393741
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Inclusion Criteria:
• Men and women with histologically or cytologically demonstrated breast cancer that is
deemed metastatic or incurable by the treating physician.
• It is medically appropriate to treat the patient with an antimitotic agent or an
intravenous control chemotherapeutic agent by IV infusion at standard doses as per the
treating physician. Please see NCCN guidelines for standard of care, p58 for standard
chemotherapy regimens for recurrent or metastatic breast cancer7.
• The patient has measureable disease as determined by RECIST 1.1.
• Archived tissue is available from either primary, metastatic site or both.
• It is safe and feasible to obtain a research tumor biopsy on cycle 1 day 2 with a
biopsy of an accessible lesion such as liver, lung, lymph node, skin, breast, or bone.
• All pre-chemotherapy test results (tests per treating oncologist discretion) have been
reviewed and deemed appropriate for planned chemotherapy by the patient's treating
oncologist.
Exclusion Criteria:
• HER2+ breast cancer by standard criteria.
• Pregnant women are excluded from this study because systemic chemotherapy may cause
deleterious effects to the fetus. Because there is an unknown but potential risk for
adverse events in nursing infants secondary to treatment of the mother with systemic
chemotherapy, breastfeeding should be discontinued if the mother is enrolled in the
trial.
• Planned treatment with hormonal therapy, or targeted oral therapy during trial
enrollment.
PSMA-based 18F-DCFPyL PET/CT and PET/MRI Pilot Studies in Prostate Cancer
The overall goal of this research is to validate and develop a non-invasive imaging biomarker
of prostate cancer detection, progression, and recurrence. Development of such a biomarker
may be useful to differentiate indolent from aggressive prostate cancer phenotypes allowing
for selection of an appropriate risk adaptive therapy.
Steve Cho
Male
18 Years and over
Early Phase 1
This study is NOT accepting healthy volunteers
NCT03232164
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Inclusion Criteria:
• Prostate cancer pathologically proven by prostate biopsy (newly diagnosed for
Sub-Study 1 and 4)
• Prostate biopsy histology grade ≥ Gleason 1, 6, 3+4, or 4+3; positive biopsy >2 cores
• Any PSA permitted
• Two consecutive rising PSA values (Sub-Study 3 only)
• Castrate-levels of testosterone •total testosterone < 50 ng/dL (Sub-Study 3 only)
• Patients considered as candidates for and medically fit to undergo prostatectomy
• At least 7 days after most recent prostate biopsy
• Imaging evidence of suspected metastatic disease, including CT, bone scan, MRI,
ultrasound or other PET modalities (Sub-Study 3 only)
• New diagnosis of prostate cancer undergoing additional biopsy evaluation (Sub--Study 4
only)
• Karnofsky performance status of at least 70 (Sub-Study 4 only)
• General health and anatomy suitable to undergo transrectal ultrasound-MRI fusion
biopsy of the identified lesions and standard 12 core sextent biopsy (Sub-Study 4
only)
Exclusion Criteria:
• Prior pelvic external beam radiation therapy or brachytherapy
• Chemotherapy for prostate cancer
• Androgen deprivation therapy for prostate cancer
• Investigational therapy for prostate cancer (Sub-Study 3 Only)
• Unable to lie flat during or tolerate PET/CT
• Prior history of any other malignancy within the last 2 years, other than skin basal
cell or cutaneous superficial squamous cell carcinoma that has not metastasized and
superficial bladder cancer.
• No prostatectomy scheduled more than 12 hours post imaging (Sub-Study 1 only)
• Serum creatinine > 2 time the upper limit of normal
• Total bilirubin > 3 times the upper limit of normal
• Liver Transaminases > 5 times the upper limit of normal
Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors
This phase I trial studies the safety of transplantation with a haploidentical donor
peripheral blood stem cell graft depleted of TCRαβ+ cells and CD19+ cells in conjunction with
the immunomodulating drug, Zoledronate, given in the post-transplant period to treat
pediatric patients with relapsed or refractory hematologic malignancies or high risk solid
tumors.
Christian Capitini, MD
All
7 Months to 21 Years old
Phase 1
This study is NOT accepting healthy volunteers
NCT02508038
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Inclusion Criteria:
• Availability of an eligible haploidentical donor
• Hematologic malignancy or solid tumor
• Patients with more than one malignancy (hematologic or solid tumor) are eligible
• Patients with hematologic malignancy must have no HLA identical sibling or suitable
unrelated donor OR time needed to find an acceptable unrelated donor match would
likely result in disease progression such that the patient may become ineligible for
any type of potentially curative transplant
• Relapsed or primary therapy-refractory AML with bone marrow blast < 20%
• High-risk refractory or relapsed ALL in patients for whom transplantation is
deemed indicated (relapse occurring < 30 months from diagnosis, patients
relapsing after previous allogeneic transplant, relapse after 2nd remission,
primary induction failure or hypodiploidy)
• Relapsed Hodgkin lymphoma unable to achieve 2nd remission or Very Good Partial
Response (VGPR) and therefore ineligible to receive autologous hematopoietic stem
cell transplant (auto-HSCT)
• Hodgkin lymphoma relapsing after auto-HSCT
• Primary refractory or relapsed non-Hodgkin lymphoma unable to achieve 2nd
remission or VGPR and therefore ineligible to receive auto-HSCT
• Non-Hodgkin lymphoma relapsing after auto-HSCT
• Myelodysplastic Syndrome/Myeloproliferative Syndrome
Solid Tumor
• Patients with solid tumor must have failed or have been ineligible to receive
auto-HSCT or if auto-HSCT would not offer > 20% chance of cure
• Neuroblastoma
• high risk with relapsed or refractory disease
• Soft tissue sarcomas (Rhabdomyosarcoma, Ewing sarcoma, Primitive Neuroectodermal Tumor
or other high-risk extracranial solid tumors)
• Relapsed or primary refractory metastatic
• 1st complete remission, but very high-risk features (i.e., < 20% survival with
conventional therapy)
• Osteosarcoma
• Failure to achieve Complete Response (CR) following initial therapy
• Relapsed with pulmonary or bone metastases and did not achieve a CR with surgery
and/or chemotherapy
• Karnofsky (patients > 16 years) or Lansky (patients 16 years or older) performance
score of ≥ 60
• Life expectancy of ≥ 3 months
• Patient must have fully recovered from acute toxic effects of all prior chemotherapy,
immunotherapy, or radiotherapy prior to entering this study
• Study enrollment no earlier than 3 months after preceding HSCT
• Glomerular Filtration Rate (GFR) ≥ 60 ml/min/1.73m2
• Total bilirubin < 3 mg/dL
• ALT (alanine aminotransferase, SCPT) ≤ 5 x Upper LImit of Normal (ULN) for age
• Ejection fraction of > 40% by Multigated Acquisition Scan (MUGA) or echocardiogram
• No evidence of dyspnea at rest
• No supplemental oxygen requirement
• If measured, carbon monoxide diffusion capacity (DLCO) >50%
• No severe peripheral neuropathy, signs of leukoencephalopathy or active Central
Nervous System (CNS) infection
• Patients with seizure disorders may be enrolled if seizures are well controlled on
anticonvulsant therapy
• If of reproductive potential, negative pregnancy test and willing to use effective
birth control method
• Informed consent from patient or legal guardian (if patient is minor)
Inclusion Criteria for Donors:
• Donor must be 18 years of age minimum, 65 years of age maximum
• Donor must be in good general health as determined by evaluating medical provider
• Must meet donor criteria for human cells, tissues, and cellular and tissue-based
products per Code of Federal Regulations 21 CFR 1271, subpart C. Specifically:
• Donor screening in accordance with 1271.75 indicates that the donor:
• Is free from risk factors for, and clinical evidence of, infection due to
relevant communicable disease agents and diseases; and
• Is free from communicable disease risks associated with xenotransplantation;
and
• The results of donor testing for relevant communicable disease agents in
accordance with 1271.80 and 1271.85 are negative or nonreactive, except as
provided in 1271.80(d)(1).
• Haploidentical by HLA-typing
• Preference will be given to donors who demonstrate KIR incompatibility with recipient
HLA class I ligands defined as the donor expressing a KIR gene for which the
corresponding HLA class I ligand is not expressed by the recipient.
• Negative testing for relevant communicable diseases:
• Hepatitis B surface antigen (HBsAg)
• Hepatitis B core antibody (Anti-HBc)
• Hepatitis C antibody (Anti-HCV)
• HIV 1 & 2 antibody (Anti-HIV-1, 2 plus O)
• HTLV I/II antibody (Anti-HTLV I/II)
• RPR (Syphilis TP)
• CMV (Capture CMV)
• MPX for: HepB (HBV-PCR), HepC (HCV-PCR), HIV (HIV-PCR)
• NAT for West Nile Virus (WNV-PCR)
• T. Cruzi •EIA (Chagas)
Exclusion Criteria:
• Pregnant or breast-feeding
• HIV infection
• Heart failure or uncontrolled cardiac rhythm disturbance
• Uncontrolled, Serious Active Infection
• Prior organ allograft
• Significant serious intercurrent illness unrelated to cancer or its treatment not
covered by other exclusion criteria expected to significantly increase the risk of
HSCT
• Any mental or physical condition, in the opinion of the PI (or PI designee), which
could interfere with the ability of the subject (or the only parent or legal guardian
available to care for the subject) to understand or adhere to the requirements of the
study
• Enrollment in any other clinical study from screening up to Day 100 (unless PI judges
such enrollment would not interfere with endpoints of this study)
Exclusion Criteria for Donors:
• Lactating females
• Pregnant females
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Myelodysplastic Syndrome, Myeloproliferative Syndrome, Rhabdomyosarcoma, Ewing Sarcoma, Primitive Neuroectodermal Tumor, Osteosarcoma, Neuroblastoma, Esophagus, Stomach, Small Intestine, Colon, Rectum, Liver, Pancreas, Lung, Other Respiratory and Intrathoracic Organs, Bones and Joints, Soft Tissue, Other Skin, Ovary, Other Female Genital, Prostate, Other Male Genital, Urinary Bladder, Kidney, Other Urinary, Eye and Orbit, Brain and Nervous System, Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma, Lymphoid Leukemia, Myeloid and Monocytic Leukemia, Leukemia, other, Other Hematopoietic, Ill-Defined Sites, Brain/Central Nervous System, Hematologic cancers, other, Leukemia, Lymphoma, Sarcoma
First, to establish a comparison of the pathophysiology of carotid atherosclerosis and the
genetic and environmental variables that cause those plaques to become symptomatic. Second,
to differentiate between vulnerable plaque and other types of plaque using ultrasound
elastography, MRI data, trans-cranial doppler along with RF (radio frequency) analysis of
back-scattered ultrasonic echoes.
Robert Dempsey, MD
All
18 Years to 80 Years old
NA
This study is NOT accepting healthy volunteers
NCT00214006
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Inclusion Criteria:
• Male and Female patients aged 18-80 presenting for carotid endarterectomy
Exclusion Criteria:
• Patients not felt suitable for carotid endarterectomy and those with impaired
decision-making capacity
The LUCINDA Trial: LeUprolide Plus Cholinesterase Inhibition to Reduce Neurological Decline in Alzheimer's (LUCINDA)
The LUCINDA Trial is a three-site, phase II, randomized, double-blind, placebo-controlled
study of leuprolide acetate (Eligard) in women with Mild Cognitive Impairment or Alzheimer's
Disease taking a stable dose of a cholinesterase inhibitor medication like donepezil. Its
objective is to assess the efficacy of a 48-week regimen of leuprolide (22.5 mg per 12 weeks)
compared to placebo on cognitive function, global function and plasma and neuroimaging
biomarkers.
Craig Atwood
Female
60 Years to 120 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT03649724
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Inclusion Criteria:
• Female, post-menopausal
• Probable AD or MCI due to AD according to NIA-AA criteria
• Taking a stable dose of a cholinesterase inhibitor such as donepezil/Aricept and
dosage likely to remain stable throughout the trial
• MOCA > 11 or blind MOCA > 8 (inclusive) at screening visit
• Hachinski score <5 supporting clinical judgment that dementia is not of vascular
origin
• Fluent in English
• has a study partner / caregiver who interacts with the subject for at least 5 hours
per week on average and can participate in evaluations
Exclusion Criteria:
• Presence based on exam, history or MRI of significant brain disease other than AD such
as schizophrenia, epilepsy, Parkinson's disease or large territory stroke
• Current substance abuse in accord with DSM V criteria
• Significantly depressed (Geriatric Depression Scale > 10)
• Physical or psychological MRI contraindications, or likely unable to tolerate
neuroimaging
• Taking other medications known to affect serum sex hormone or gonadotropin
concentrations such as estrogen and/or progesterone for hormone replacement therapy,
goserelin or danazol
• Presence of significant systemic illness likely to interfere with participation in or
completion of the study or to affect study results such as cancer within 5 years
(other than non-melanoma skin cancer), autoimmune disease, recent myocardial
infarction, signs/symptoms of organ failure based on history, ECG, screening
laboratory and/or physical exams
• Receiving other investigational drugs within 30 days or 5 half-lives prior to
randomization, whichever is longer
pTVG-HP DNA Vaccine With or Without pTVG-AR DNA Vaccine and Pembrolizumab in Patients With Castration-Resistant, Metastatic Prostate Cancer
This trial will evaluate the use of one versus two DNA vaccines, delivered concurrently with
PD-1 blockade using pembrolizumab followed by treatment with pembrolizumab alone, and
delivered over a prolonged period of time (for a maximum of 2 years (32 cycles) or until
radiographic progression) on the treatment of castrate-resistant, metastatic prostate cancer.
The hypothesis to be tested is that delivering two vaccines with PD-1 blockade will elicit a
greater frequency and magnitude of tumor-directed CD8+ T cells, and thereby increase the
percentage of patients experiencing objective anti-tumor effect as measured by PSA declines
and/or objective radiographic responses. Participants must be 18 years of age or older and
can expect to be on treatment for 2 years (32 cycles) and on study for up to 4 years
(including 2 years of follow up via phone).
Christos Kyriakopoulos, MD
Male
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT04090528
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Inclusion Criteria:
• Histologically confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate)
• Metastatic disease as evidenced by the presence of soft tissue and/or bone metastases
on imaging studies (CT of abdomen/pelvis, bone scintigraphy)
• Castrate-resistant disease, defined as follows:
• All participants must have received (and be receiving) standard of care androgen
deprivation treatment (surgical castration versus GnRH analogue or antagonist
treatment); subjects receiving Gonadotropin-releasing hormone (GnRH) analogue or
antagonist must continue this treatment throughout the time on this study.
• Participants may or may not have been treated previously with a nonsteroidal
antiandrogen. For participants previously treated with an antiandrogen, they must
be off use of anti-androgen for at least 4 weeks (for flutamide, apalutamide,
enzalutamide, or other 2nd generation AR antagonists) or 6 weeks (for
bicalutamide or nilutamide) prior to registration. Moreover, participants who
demonstrate an anti-androgen withdrawal response, defined as a > 25% decline in
PSA within 4-6 week of stopping a nonsteroidal antiandrogen, are not eligible
until the PSA rises above the nadir observed after antiandrogen withdrawal.
• Participants must have a castrate serum level of testosterone (< 50 ng/dL) within
6 weeks of day 1
• Progressive disease while receiving androgen deprivation therapy defined by any one of
the following as per the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) bone
scan criteria or RECIST 1.1 during or after completing last therapy:
• PSA: At least two consecutive rises in serum PSA, obtained at a minimum of 1-week
intervals, with the final value > 2.0 ng/mL.
• Measurable disease: > 50% increase in the sum of the cross products of all
measurable lesions or the development of new measurable lesions. The short axis
of a target lymph node must be at least 15 mm by spiral CT to be considered a
target lesion
• Non-measurable (bone) disease: The appearance of two or more new areas of uptake
on bone scan (or Sodium Fluoride (NaF) positron emission tomography-computed
tomography (PET/CT)) consistent with metastatic disease compared to previous
imaging during castration therapy. The increased uptake of pre-existing lesions
on bone scan will not be taken to constitute progression, and ambiguous results
must be confirmed by other imaging modalities (e.g. X-ray, CT or MRI).
• Prior treatment with abiraterone or enzalutamide is permitted, but participants must
have weaned to a daily corticosteroid dose equivalent of no more than 5 mg prednisone
daily for at least 28 days prior to day 1.
• Life expectancy of at least 6 months
• Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status
of 0, 1, or 2.
• Adequate hematologic, renal, liver, and coagulation function as evidenced by the
following within 6 weeks of day 1:
• White Blood Cells (WBC) >/= 2000 / mm3
• Absolute Neutrophil Count (ANC) >/= 1500 / mm3
• Hemoglobin (HgB) >/= 9.0 gm/dL (Participants must not have received a blood
transfusion within 14 days)
• Platelets >/= 100,000 / mm3
• Creatinine = 1.5 x institutional upper limit of normal (ULN)
• Total bilirubin = 1.5 x institutional ULN OR direct bilirubin = ULN for
participants with total bilirubin levels > 1.5 x ULN
• Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) = 2.5 x
institutional upper limit of normal
• Prothrombin Time (PT) or International Normalized Ratio (INR) = 1.5 x ULN
unless participant is receiving anticoagulant therapy and PT is within
therapeutic range of intended use of anticoagulant (only required for
participants receiving biopsy)
• Partial Thromboplastin Time (PTT) = 1.5 x ULN unless participant is receiving
anticoagulant therapy and a PTT is within therapeutic range of intended use of
anticoagulant (only required for participants receiving biopsy)
• No known history of human immunodeficiency viruses (HIV 1 and 2), Human T-cell
leukemia virus type 1 (HTLV-1), or active Hepatitis B or Hepatitis C
• Participants must be at least 4 weeks from any prior treatments and have recovered (to
< Grade 2) from acute toxicity attributed to this prior treatment, unless considered
chronic
• A subset of participants (6 participants per treatment arm) treated at the lead
University of Wisconsin (UW) site must be willing and able (in the opinion of the
treating physician) to undergo two research biopsies for the investigational component
of this trial.
• A subset of participants (6 participants per treatment arm) treated at the lead UW
site must be willing to undergo NaF PET/CT scans for the investigational component of
this trial.
• For those participants who are sexually active, they must be willing to use barrier
contraceptive methods, and refrain from donating sperm, during the period of treatment
on this trial and for four weeks after the last DNA immunization treatment
• Participants must be informed of the experimental nature of the study and its
potential risks, and must sign an Institutional Review Board (IRB)-approved written
informed consent form indicating such an understanding
Exclusion Criteria:
• Small cell or other variant (non-adenocarcinoma) prostate cancer histology, unless
there is evidence that the tumor expresses PAP
• Participants may not be receiving other investigational agents or be receiving
concurrent anticancer therapy other than standard androgen deprivation therapy
• Concurrent bisphosphonate therapy is not excluded, however participants should not
start bisphosphonate therapy while on this study; those participants already receiving
bisphosphonate therapy should continue at the same dosing and schedule as prior to
study entry
• Rapidly progressive symptomatic metastatic disease, as defined by the need for
increased opioid analgesics within one month of registration for the treatment of pain
attributed to a prostate cancer metastatic lesion; participants receiving opioids must
receive approval from the PI for eligibility
• Treatment with any of the following medications within 28 days of day 1, or while on
study, is prohibited:
• Systemic corticosteroids (at doses over the equivalent of 5 mg prednisone daily);
inhaled, intranasal or topical corticosteroids are acceptable
• Prostate Cancer and spes (PC-SPES)
• Megestrol
• Ketoconazole
• 5-α-reductase inhibitors •participants already taking 5-α-reductase inhibitors
prior to 28 days prior to registration may stay on these agents throughout the
course of therapy, but these should not be started while participants are on
study
• Diethyl stilbesterol
• Abiraterone
• Enzalutamide
• Apalutamide
• Radium 223 (Xofigo®)
• Any other hormonal agent or supplement being used with the intent of cancer
treatment must be reviewed by the PI for eligibility
• External beam radiation therapy within 4 weeks of registration is prohibited, or
anticipated need for radiation therapy (e.g. imminent pathological fracture or spinal
cord compression) within 3 months of registration. Participants must have recovered
from all radiation-related toxicities and not have had radiation pneumonitis.
• Major surgery within 4 weeks of registration is prohibited
• Prior cytotoxic chemotherapy (for example, but not limited to, docetaxel,
mitoxantrone, cabazitaxel) within 28 days of registration is prohibited
• Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with any agent
directed to another T-cell stimulatory or inhibitory receptor (e.g. CTLA-4, OX-40,
CD137).
• Participants with a history of life-threatening autoimmune disease
• Participants with a history of non-infectious pneumonitis that required corticosteroid
treatment, or has current pneumonitis
• Participants with a history of allergic reactions to the tetanus vaccine
• Participants who have undergone splenectomy or who have a diagnosis of
immunodeficiency
• Participants must not have other active malignancies other than non-melanoma skin
cancers or superficial (non-muscle-invasive) carcinoma of the bladder. Participants
with a history of other cancers who have been adequately treated and have been
recurrence-free for > 3 years are eligible.
• Participants with known brain metastases and/or carcinomatous meningitis
• Participants who have received a live vaccine within 30 days prior to the first dose
of study drug. Examples of live vaccines include, but are not limited to, the
following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever,
rabies, Bacillus Calmette •Guérin (BCG), and typhoid vaccine. Seasonal influenza
vaccines for injection are generally killed virus vaccines and are allowed; however,
intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not
allowed.
• Any antibiotic therapy within 1 month of day 1, or anticipated need for antibiotic
therapy within 1 month of beginning treatment
• Participants with active autoimmune disease that has required systemic treatment in
the past 2 years (i.e. with use of disease modifying agents, corticosteroids or
immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic
corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is
not considered a form of systemic treatment.
• Any other medical intervention or condition, which, in the opinion of the PI or
treating physician, could compromise participant safety or adherence with the study
requirements (including biopsies), or confound results of the study, over the
treatment period.
• Any known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirement of the trial.
• Participants cannot have concurrent enrollment on other phase I, II, or III
investigational treatment studies.
Prostate, Castration-resistant Prostate Cancer, Metastatic Cancer, Prostate Cancer
NAN-101 in Patients With Class III Heart Failure (NAN-CS101)
This is a Phase 1, prospective, multi-center, open-label, sequential dose escalation study to
explore the safety, feasibility, and efficacy of a single intracoronary infusion of
BNP116.sc-CMV.I1c in patients with NYHA Class III heart failure. Patients with symptomatic
congestive heart failure will be enrolled until up to 12 subjects have received infusions of
investigational product. All patients will be followed until 12 months post treatment
intervention, and then undergo long-term follow-up via semi-structured telephone
questionnaires every 6 months for an additional 24 months (+/- 30 days).
David Murray, MD
All
18 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT04179643
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Inclusion criteria:
• Age >18 years of age
• Chronic non-ischemic cardiomyopathy
• LVEF 15% ≤ 30% by transthoracic echocardiography (TTE) within 6 months prior to
enrollment
• NYHA Class III HF for a minimum of 3 months HF despite appropriate medical therapy
(defined below):
• Treatment with appropriate HF therapy as tolerated, including, but not limited
to:
• Beta blocker therapy and angiotensin converting enzyme (ACE) inhibitor or
angiotensin receptor blocker (ARB) or sacubitril/valsartan combination therapy
(Entresto) for ≥ 90 days prior to enrollment. May also receive aldosterone
antagonist therapy. Doses of the above medications must be stable for ≥ 30 days
prior to enrollment; and
• Cardiac resynchronization therapy (CRT), if clinically indicated, must have been
implanted ≥ 90 days prior to enrollment. Internal cardioverter defibrillator
(ICD) must be implanted, if clinically indicated ≥ 30 days prior to enrollment
• Females of childbearing potential must use at least one of the following acceptable
birth control methods throughout the study and for 6 months after IP administration:
• Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6
months minimum prior to IP administration
• Intrauterine device in place for at least 90 days prior to receiving IP
• Barrier methods (diaphragm plus spermicide or condom) starting at least 30 days prior
to receiving IP
• Abstinence (the subject must be willing to remain abstinent from screening to 6 months
after receiving IP). Females are allowed to claim abstinence as their method of
contraception only when it is the preferred and usual lifestyle of the subject
• Surgical sterilization of the partner(s) (vasectomy) for >180 days prior to IP
administration
• Hormonal contraceptives starting > 90 days prior to IP. If hormonal contraceptives are
started less than 90 days prior to receiving IP, subjects must agree to use a barrier
method (diaphragm plus spermicide or condom) from screening through 90 days after
initiation of hormonal contraceptives
• Males subjects capable of fathering a child:
• Must agree to use a condom from IP administration through 6 months after the time of
IP administration
• Must agree not to donate sperm for 6 months after time of receiving IP
• Documented evidence of vasectomy in males for 180 days minimum prior to receiving IP
is an acceptable form of contraception
• Males who claim abstinence as their method of contraception are allowed provided they
agree to use barrier methods should they become sexually active from screening through
6 months after receiving IP. Males are allowed to claim abstinence as their method of
contraception only when it is the preferred and usual lifestyle of the subject
• Ability to sign Informed Consent Form (ICF) and Release of Medical Information Form
• Appropriate candidate for protocol-specified intracoronary infusion in the judgment of
the infusing interventional cardiologist
Cohort 3: medical history documentation of PLN-R14Del mutation and an ICD in situ (at least
30 days prior to enrollment)
Exclusion Criteria:
• Chronic ischemic cardiomyopathy
• Intravenous (IV) inotropic therapy, intra-aortic balloon pump (IABP) or percutaneous
cardiac assist device therapy within 30 days prior to enrollment
• Restrictive cardiomyopathy, obstructive cardiomyopathy, pericardial disease,
amyloidosis, infiltrative cardiomyopathy, uncorrected thyroid disease, or dyskinetic
LV aneurysm
• Cardiac surgery or percutaneous coronary intervention (PCI) within 30 days prior to
enrollment
• Third degree heart block
• Clinically significant myocardial infarction (MI) in the judgment of the subject's
physician (e.g., ST elevation MI [STEMI] or large non-STEMI) within 6 months prior to
enrollment
• Prior heart transplantation, left ventricular reduction surgery (LVRS),
cardiomyoplasty, passive restraint device (e.g., CorCap™ Cardiac Support Device),
surgically implanted LVAD or cardiac shunt
• Likely to receive cardiac resynchronization therapy, cardiomyoplasty, LV reduction
surgery, heart transplant, conventional revascularization procedure, or valvular
repair within 3 months of IP dosing
• Known hypersensitivity to contrast dyes used for angiography; history of, or likely
need for, high-dose steroid pretreatment prior to contrast angiography
• Expected survival < 1 year in the judgment of the investigator
• Active or suspected infection within 48 hours prior to enrollment as evidenced by
fever or positive culture
• Known intrinsic liver disease (e.g., cirrhosis, hepatitis A, chronic hepatitis B or
hepatitis C virus infection). If serology is positive and PCR is negative, subject may
be eligible (confirm with medical monitor).
• Liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase
[AST], alkaline phosphatase) > 2x upper limit of normal (ULN) within 30 days prior to
enrollment.
• Renal Failure, dialysis dependent or serum creatinine > 2.5 mg/dl within 30 days prior
to enrollment
• Bleeding diathesis or thrombocytopenia defined as platelets <50,000 platelets/μL
within 30 days prior to enrollment
• Anemia defined as hemoglobin <10 g/dL or transfusion dependent within 30 days prior to
enrollment
• Neutropenia defined as absolute neutrophils <1500 mm3 within 30 days prior to
enrollment
• Known AIDS or HIV-positive status, or a previous diagnosis of immunodeficiency with an
absolute neutrophil count <1000 cells/mm3
• Previous participation in a study of gene transfer
• Receiving investigational intervention or participating in another clinical study
within 30 days or within 5 half-lives of another investigational drug administration
prior to administration of NAN-101 that may impact the therapeutic potential of
NAN-101.
• Pregnancy or breastfeeding at the time of screening
Childhood Allergy and the Neonatal Environment (CANOE)
The purpose of this research study is to study the relationship between childhood asthma,
allergies, and early-life environmental factors that may cause childhood asthma and
allergies. Previous birth cohort studies have found early-life environmental factors such as
allergies, pollutants, viruses and bacteria have all contributed to the development of asthma
and allergies. Investigators are doing this research because there continues to be a strong
need to understand the root causes of asthma and allergies. The CANOE study is an
observational cohort study, which means investigators are not asking participants or
participant's child to change their medications and investigators will not be giving
participants or participant's child a study drug.
Anne Singh
All
Not specified
NA
This study is NOT accepting healthy volunteers
NCT04215783
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Inclusion Criteria:
1. History of or concurrent asthma or allergic rhinitis (hay fever) in either biologic
parent or sibling (at least one shared biological parent) by parental report. The
presence of paternal or sibling allergy or asthma will be ascertained by maternal
report.
2. Maternal age greater than or equal to 18 years at the time of study enrollment.
Exclusion Criteria:
1. Maternal HIV infection at time of delivery.
2. Plans for the family to move out of the geographic area during the period of the
study.
3. Does not speak English.
4. Current maternal use of progesterone during pregnancy to prevent preterm birth.
• Progesterone use is only an exclusion if currently being taken at time of
enrollment for preterm birth. Previous use to prevent preterm birth or use at any
time for other indications is allowed.
5. Pregnancy is a result of an embryo donor (egg and sperm donor pregnancies are
permitted).
6. Past or current medical problems or findings from physical examination or laboratory
testing which, in the opinion of the investigator or designee, may pose additional
risks from participation in the study, may interfere with the participant's ability to
comply with study requirements or that may impact the quality or interpretation of the
data obtained from the study.
Asthma in Children, Allergy, Allergic rhinitis due to animal (cat) (dog) hair and dander, Allergic rhinitis due to food, Allergic rhinitis due to pollen, Asthma, Other, Infections, Immune System & Allergies
Nivolumab With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma
This is a Phase I/II, multicenter, open-label, dose escalation/dose-expansion study to
evaluate the tolerability, safety, and the maximum tolerated dose (MTD) of ruxolitinib when
given with fixed dose nivolumab in patients with relapsed or refractory classical Hodgkin
lymphoma (cHL).
Vaishalee Kenkre, MD
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT03681561
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Inclusion Criteria:
• Written informed consent and HIPAA authorization for release of personal health
information. NOTE: HIPAA authorization may be included in the informed consent or
obtained separately.
• Age ≥ 18 years at the time of consent.
• ECOG Performance Status of 0, 1 or 2.
• Histologically confirmed diagnosis of classical Hodgkin lymphoma that is relapsed or
refractory •historical biopsy at last relapse is acceptable. NOTE: a repeat biopsy is
not required for Phase I if the historical biopsy was performed at the most recent
relapse, without remission in between. A fresh biopsy is not required for Phase II.
• Presence of radiographically measurable disease (defined as the presence one or more ≥
1.5 cm lesions, as measured in the longest dimension by PET/CT) within 4 weeks of
study registration.
• Prior therapy with check-point inhibitors (nivolumab, pembrolizumab, others) and
subsequent progressive disease, stable disease or mixed response
• Failed at least 2 prior therapies including cytotoxic chemotherapy including ABVD or
similar, autologous transplantation, brentuximab vedotin, allogenic transplantation
without active graft versus host disease Note: Patients who are eligible and willing
to undergo autologous transplant should not be enrolled on this trial
• Prior cancer treatment must be completed at least 14 days prior to registration and
the patient must have recovered from all reversible acute toxic effects of the regimen
(other than alopecia) to ≤Grade 1 or baseline. Radiation therapy must be completed at
least 7 days prior to registration.
• Absolute Neutrophil Count ≥ 1000/μL
• Platelets ≥ 75,000/μL (or ≥50,000/mm3 if known BM involvement)
• Calculated creatinine clearance ≥ 40 cc/min using the Cockcroft-Gault formula
• Bilirubin ≤ 1.5 x upper limit of normal (ULN)
• Aspartate aminotransferase (AST) ≤ 2.5 × ULN
• Alanine aminotransferase (ALT) ≤ 2.5 × ULN
• Females of childbearing potential must have a negative serum pregnancy test within 7
days prior to registration. NOTE: Females are considered of child bearing potential
unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal
ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least
12 consecutive months
• Males who are sexually active with partners of child-bearing potential must be willing
to abstain from heterosexual activity or adhere to contraception from the time of
written consent until 7 months after treatment discontinuation.
• Patient must provide voluntary written informed consent prior to the performance of
any research related tests or procedures.
Exclusion Criteria:
• Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the
mother is being treated on study).
• Inability or unwillingness to swallow oral medication or any condition that precludes
the administration and/or absorption of oral medications
• A life-threatening illness, medical condition or organ system dysfunction, which in
the investigator's opinion, could compromise the patient's safety, interfere with the
metabolism of study drugs, or put the study outcomes at undue risk
• Active central nervous system (CNS) involvement by lymphoma
• Uncontrolled cardiovascular disease such as uncontrolled or symptomatic arrhythmias,
congestive heart failure, or myocardial infarction or any class 3 or 4 cardiac disease
as defined by the New York Heart Association Functional Classification
• Concomitant therapy with immunosuppressive agents, including systemic corticosteroids
(doses ≤ 10 mg/day prednisone or equivalent are permitted).
• Has a history of autoimmune disease now or in past 3 years such as hepatitis,
nephritis, hyperthyroidism, interstitial lung disease or colitis except vitiligo or
alopecia, hypothyroidism (eg, following Hashimoto syndrome) stable on hormone
replacement or psoriasis not requiring systemic treatment
• HIV-infected patients on effective anti-retroviral therapy with undetectable viral
load within 6 months of registration are eligible for this trial.
• Active Hepatitis B or C infection (defined as a positive Hepatitis B surface antigen
(Ag) or detectable viral load by PCR). NOTES: Hepatitis B and C testing is required.
Patients with positive Hepatitis B Ag may enroll if PCR is negative. Suppressive
antiviral therapy should be considered for these patients as clinically indicated.
• Currently active, clinically significant hepatic impairment Child-Pugh class B or C
• Currently receiving a strong CYP3A4 Inhibitor (such as but not limited to boceprevir
clarithromycin, conivaptan, grapefruit juice, indinavir, itraconazole, ketoconazole,
lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir,
saquinavir, telaprevir, telithromycin, voriconazole) or Fluconazole >200 mg/day.
Washout period of 1 week is required.
• History of stroke or intracranial hemorrhage within 6 months of study registration
Androgen Deprivation Therapy (ADT) and Pembrolizumab for Advanced Stage Androgen Receptor-positive Salivary Gland Carcinoma
A Phase II, multi-center, single-arm, non-blinded study combining androgen deprivation
therapy (ADT) and pembrolizumab for patients with metastatic or locally recurrent androgen
receptor-positive salivary gland carcinoma, not amenable to surgery or radiation.
Justine Bruce, MD
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT03942653
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Inclusion Criteria:
• Written informed consent and HIPAA authorization for release of personal health
information. NOTE: HIPAA authorization may be included in the informed consent or
obtained separately.
• Age ≥ 18 years at the time of consent.
• Locally advanced, recurrent, or metastatic salivary gland carcinoma that is not
amenable to curative surgery or radiation
• ECOG Performance Status of 0 or 1 within 28 days prior to registration.
• Local, pathologic testing of androgen receptor-positive salivary gland carcinoma will
be performed as standard of care. Archival tissue must be available for central
confirmation of androgen receptor-positive disease and for correlative studies. AR
positivity will be defined according to IHC staining of tumor tissue with at least 20%
of tumor staining positive with moderate intensity (1+ or greater).
• Measurable disease according to RECIST v1.1 for solid tumors within 28 days prior to
registration.
• For patients who have been treated with prior therapy, patients must have documented
progression of disease on their prior therapy for entry into the study.
• Patients with prior chemotherapy, radiation, or surgery as part of curative intent
therapy are allowed. Any number of prior lines of systemic therapy is permitted for
entry into this study so long as prior therapy did not include anti-androgen therapy
or immune checkpoint blockade.
• If prior cancer treatment, the subject must have recovered from toxic effects of prior
cancer treatment (other than alopecia) to ≤ Grade 1.
• Adequate organ function as defined below; all screening labs to be obtained within 28
days prior to registration.
• Absolute neutrophil count (ANC) ≥1500/µL
• Platelets ≥100,000/µL
• Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L
• Creatinine (Cr) OR Measured or calculated creatinine clearance (GFR can also be
used in place of Cr or creatinine clearance) ≤1.5 × ULN OR
≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN
• Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total
bilirubin levels >1.5 × ULN
• AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver
metastases) o International normalized ratio (INR) OR prothrombin time (PT) &
aPTT ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as
PT or aPTT is within therapeutic range of intended use of anticoagulants
• A male participant must agree to use contraception during the treatment period and for
at least 8 months after the last dose of study treatment and refrain from donating
sperm during this period.
• Females of childbearing potential must have a negative serum pregnancy test within 72
hours prior to registration. NOTE: Females are considered of child bearing potential
unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal
ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least
12 consecutive months
• Females of childbearing potential and males with partners of childbearing potential
must be willing to abstain from heterosexual activity or to use a highly effect form
of contraception from the time of informed consent until 8 months after treatment
discontinuation.
• As determined by the enrolling physician or protocol designee, ability of the subject
to understand and comply with study procedures for the entire length of the study
Exclusion Criteria:
• Women of childbearing age with a positive serum pregnancy test within 72 hours prior
to study registration.
• Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with
an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4,
OX40, CD137).
• Has received prior androgen deprivation therapy including orchiectomy,
gonadotropin-releasing hormone (GnRH) agonists/antagonists, androgen receptor blocker,
abiraterone, or enzalutamide.
• Has received prior systemic anti-cancer therapy including investigational agents
within 14 days prior to registration.
• Has had an allogenic tissue or solid organ transplant.
• Has received prior palliative radiotherapy within 7 days of start of study treatment.
Participants must have recovered from all radiation-related toxicities and require
less than 10mg of prednisone (or equivalent corticosteroid) daily.
• Has received a live vaccine or live-attenuated vaccine within 28 days prior to the
first dose of study drug. Administration of killed vaccines is allowed.
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
(in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of
immunosuppressive therapy within 7 days prior to the first dose of study drug.
• Has a known additional malignancy that is progressing or has required active treatment
within the past 2 years. Note: Participants with basal cell carcinoma of the skin,
squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast ductal
carcinoma in situ, cervical cancer in situ) that have undergone potentially curative
therapy are not excluded.
• Has known active CNS metastases and/or carcinomatous meningitis. Participants with
previously treated brain metastases may participate provided they are radiologically
stable, i.e. without evidence of progression for at least 14 days by repeat imaging
(note that the repeat imaging should be performed during study screening), clinically
stable, and without requirement of steroid treatment for at least 14 days prior to
first dose of study treatment.
• Has ≥Grade 3 hypersensitivity to pembrolizumab and/or any of its excipients.
• Has active autoimmune disease that has required systemic treatment in the past 2 years
(i.e. with use of disease modifying agents, corticosteroids or immunosuppressive
drugs). Replacement therapy (eg, levothyroxine, insulin, or physiologic corticosteroid
replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a
form of systemic treatment.
• Has a history of (non-infectious) pneumonitis/interstitial lung disease that required
steroids or has current pneumonitis/interstitial lung disease.
• Has an active infection requiring systemic therapy.
• Has a known history of Human Immunodeficiency Virus (HIV).
• Has a known history of active TB (Bacillus Tuberculosis).
• Has a history or current evidence of any condition, therapy, or laboratory abnormality
that might confound the results of the study, interfere with the subject's
participation for the full duration of the study, or is not in the best interest of
the subject to participate, in the opinion of the treating investigator.
• Has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial.
• Is pregnant or breastfeeding or expecting to conceive or father children within the
projected duration of the study, starting with the screening visit through 120 days
after the last dose of trial treatment.
Salivary Gland Carcinoma, Lip, Oral Cavity and Pharynx, Head and Neck
This is an open label, multi-institutional, single arm phase II trial of ribociclib in
combination with bicalutamide in advanced AR+ triple-negative breast cancer. No randomization
or blinding is involved.
Kari Wisinski, MD
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT03090165
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Individuals from populations who are underrepresented in clinical research (e.g., racial
and ethnic minorities, women, individuals from rural/frontier communities, older
individuals) will be enrolled with a goal of ensuring that all eligible patients are given
the opportunity to participate in novel clinical trials and that research findings can be
generalizable to the entire population.
Androgen Receptor (AR) positivity definitions -Phase I: Metastatic or unresectable AR+
triple-negative breast cancer (TNBC); AR positivity defined as IHC staining of >0% of tumor
nuclei.
OR
-Phase II: Metastatic or unresectable AR+ triple-negative breast cancer (TNBC); AR
positivity defined as IHC staining of ≥10% of tumor nuclei.
Inclusion Criteria for Phase I and II study.
In addition to being AR positive as defined in protocol, subjects must also meet all of the
following applicable inclusion criteria.
• Histological or cytological confirmed, metastatic or unresectable triple-negative
breast cancer (TNBC). TNBC will be defined as expression of ER<10%, PR< 10% and HER2
negative either by IHC (0, 1+ are negative, 2+ equivocal) or in situ hybridization
method (ratio <2.0 is negative).
• Written informed consent and HIPAA authorization for release of personal health
information. NOTE: HIPAA authorization may be included in the informed consent or
obtained separately.
• Up to 3 prior line of systemic therapy for metastatic disease is allowed. Combination
therapy will be considered 1 line.
• Age ≥ 18 years at the time of consent.
• ECOG Performance Status of 0, 1 or 2 within 28 days prior to registration.
• Life expectancy of > 12 weeks as determined by the treating physician.
• Measurable disease according to RECIST 1.1 within 28 days prior to registration.
• No active central nervous system (CNS) metastatic disease. NOTE: Subjects with CNS
involvement must meet ALL of the following to be eligible:
• At least 28 days from prior definitive treatment of their CNS disease by surgical
resection, stereotactic body radiation therapy (SBRT) or whole brain radiation
treatment (WBRT) at the time of registration
• AND asymptomatic and off systemic corticosteroids and/or enzyme-inducing
anti-epileptic medications for brain metastases for >14 days prior to
registration.
• Prior cancer treatment must be completed at least 14 days prior to registration and
the subject must have recovered from all reversible acute toxic effects of the regimen
(other than alopecia) to ≤grade 1 or to baseline prior to initiation of that therapy.
• Screening rate-corrected QT interval (QTc) must be <450msec and a resting heart rate
of at least 50-90 bpm via a standard 12-lead ECG within 28 days prior to registration.
• Demonstrate adequate bone marrow and organ function as defined in the protocol; all
screening labs to be obtained within 28 days prior to registration.
• Females of childbearing potential must have a negative serum pregnancy test within 7
days prior to registration. NOTE: Females are considered of child bearing potential
unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal
ligation, or bilateral oophorectomy), or they are naturally postmenopausal for at
least 12 consecutive months, or her male partner has had a vasectomy at least 6 months
prior to screening (The sterilized male partner must be her only sexual partner.).
• Females of childbearing potential and males must be willing to abstain from
heterosexual activity or must agree to use adequate contraception (hormonal or barrier
method) for the duration of study participation and for 3 weeks after discontinuation
of study treatment.
• As determined by the enrolling physician or protocol designee, ability of the subject
to understand and comply with study procedures for the entire length of the study.
• Able to swallow bicalutamide and ribociclib tablets.
Exclusion Criteria:
• Prior therapy with AR antagonists including but not limited to bicalutamide,
enzalutamide, abiraterone and orteronel.
• Prior therapy with any CDK 4/6 inhibitors with the exception of participation in a
window or preoperative study for Stage I-III operable breast cancer..
• Active infection requiring systemic therapy.
• Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the
mother is being treated on study).
• Known additional malignancy that is active and/or progressive requiring treatment;
exceptions include basal cell or squamous cell skin cancer, in situ cervical or
bladder cancer, or other cancer for which the subject has been disease-free for at
least three years.
• Treatment with any investigational drug within 14 days prior to registration or within
5 half-lives of the investigational product, whichever is longer. Immunotherapies such
as PD-L1 or PD-1 inhibitors only require a 14 day window, regardless of half-life.
Investigational imaging agents are not included in this definition and are allowed.
• Subject who has received radiotherapy <14 days prior to registration, and who has not
recovered to grade 1 or better from related side effects of such therapy (exceptions
include alopecia and any adverse events deemed by the investigator to be unlikely to
interfere with the study drug safety).
• Subject has had major surgery within 14 days prior to registration or has not
recovered from major side effects of the surgery (tumor biopsy is not considered as
major surgery).
• Known hypersensitivity to any of the excipients of ribociclib or bicalutamide.
• Any impairment of gastrointestinal (GI) function or GI disease that may significantly
alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled
nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
• Known history of HIV infection (testing not mandatory).
• Any concurrent severe and/or uncontrolled medical condition that would, in the
investigator's judgment, cause unacceptable safety risks, contraindicate subject
participation in the clinical study or compromise compliance with the protocol (e.g.
chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled
fungal, bacterial or viral infections, etc.).
• Subjects with any of the following conditions are excluded:
• Serious or non-healing wound, ulcer, or bone fracture.
• History of abdominal fistula, gastrointestinal perforation, or intra- abdominal
abscess within 28 days prior to registration.
• Any history of cerebrovascular accident (CVA) or transient ischemic attack within
12 months prior to registration.
• Any history of arterial or venous thrombosis/thromboembolic event, including
pulmonary embolism within the past 12 months prior to registration.
• History of acute coronary syndromes (including myocardial infarction, unstable
angina, coronary artery bypass grafting, coronary angioplasty, or stenting) or
symptomatic pericarditis within 6 months prior to registration.
• Symptomatic congestive heart failure (New York Heart Association III-IV) or
documented current cardiomyopathy with left ventricular ejection fraction (LVEF)
<50%
• Clinically significant cardiac arrhythmias (e.g. ventricular tachycardia) or
clinically significant, complete left bundle branch block, high-grade AV block
(e.g. bifascicular block, Mobitz type II and third-degree AV block).
• Any episode of atrial fibrillation in the prior 12 months.
• Long QT syndrome or family history of idiopathic sudden death or congenital long
QT syndrome.
• Concomitant use of medication(s) with a known risk to prolong the QT interval
and/or known to cause Torsades de Pointe that cannot be discontinued (within 5
half-lives or 7 days prior to starting study drug) or replaced by safe
alternative medication. See ManualDocuments/Info tab of the EDC for list of
medications.
• Systolic blood pressure (SBP) >160 mmHg or <90 mmHg at screening.
• Currently receiving any known strong inducers or inhibitors of CYP3A4/5 which cannot
be discontinued 7 days prior to starting study drug (see Appendix 1 for details).
• Subject is currently receiving or has received systemic corticosteroids <14 days prior
to starting study drugs. The following uses of corticosteroids are permitted: a short
duration (<5 days) of systemic corticosteroidssingle doses, any duration of topical
applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways
diseases), eye drops or local injections (e.g., intra-articular).
• Subject is currently receiving warfarin or other coumarin-derived anticoagulant for
treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight
heparin (LMWH), novel oral anticoagulants (NOACs) or fondaparinux is allowed.
• In subjects with a diagnosis of cirrhosis, sSubjects with a Child-Pugh score B or C
are excluded. Please see chart in the ManualDocuments/Info tab of the electronic data
capture system (EDC) for Child-Pugh score calculation. If subject does not have
diagnosed or suspected cirrhosis, the Child-Pugh score does not need to be calculated.
• Subjects taking herbal supplements (St. John's Wort, gingko balboa, etc.) must
discontinue these supplements 14 days prior to study registration.
• Consumption of grapefruit, grapefruit hybrids, pummelos, star-fruit, Seville oranges
or products containing the juice of each within 7 days prior to study registration.
Dose Escalation Study of CLR 131 in Children, Adolescents, and Young Adults With Relapsed or Refractory Malignant Tumors Including But Not Limited to Neuroblastoma, Rhabdomyosarcoma, Ewings Sarcoma, and Osteosarcoma (CLOVER-2)
The study evaluates CLR 131 in children, adolescents, and young adults with relapsed or
refractory malignant solid tumors and lymphoma and recurrent or refractory malignant brain
tumors for which there are no standard treatment options with curative potential.
Nicholas Pytel, DO
All
2 Years to 25 Years old
Phase 1
This study is NOT accepting healthy volunteers
NCT03478462
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Inclusion Criteria:
All Patients
• Previously confirmed (histologically or cytologically) pediatric solid tumor (e.g.,
neuroblastoma, sarcoma), lymphoma (including Hodgkin's lymphoma), or malignant brain
tumors that are clinically or radiographically suspected to be relapsed, refractory,
or recurrent for which there are no standard treatment options with curative
potential. Note: patients with diffuse intrinsic pontine glioma (DIPG) may enroll
without histological or cytological confirmation.
• ≥ 2 years of age and ≤ 25 years of age at time of consent/assent
• If ≥ age 16 years, Karnofsky performance status of ≥ 60. If < age 16 years, Lansky
performance status ≥ 60
• Platelets ≥ 75,000/µL (last transfusion, if any, must be at least 1 week prior to
study registration, and, unless deemed medically necessary, no transfusions are
allowed between registration and dosing)
• Absolute neutrophil count ≥ 750/µL
• Hemoglobin ≥ 8 g/dL (last transfusion must be at least 1 week prior to study
registration, and, unless deemed medically necessary, no transfusions are allowed
between registration and dosing)
• Using the bedside Schwartz formula, estimated GFR (creatinine clearance) > 60
ml/min/1.73m2
• Alanine aminotransferase < 3 × ULN
• Bilirubin < 2 × ULN
• Patients who have undergone autologous or allogeneic bone marrow transplant must be at
least 3 months from transplant.
• Patients enrolling at total dose levels > 30 millicurie (mCi)/m2 must have
availability or ability to collect an autologous hematopoietic stem cell back-up
product prior to CLR 131 administration. At minimum, 2 x 10^6/kg cryopreserved CD34+
cells must be available.
• Patient or his or her legal representative is judged by the Investigator to have the
initiative and means to be compliant with the protocol.
Patients with Pediatric Solid Tumor or Lymphoma
• At least 1 measurable lesion with longest diameter of at least 10 mm. Patients with a
lesion(s) that are determined to be Metaiodobenzylguanidine (MIBG) or positron
emission tomography (PET) positive may be enrolled at the investigator's discretion,
even if not associated with a measurable lesion of at least 10 mm. Patients with
neuroblastoma who have detectable disease may enroll provided they meet the
requirements of the International Neuroblastoma Response Criteria.
• Patients with known brain metastases must have completed any radiotherapy or systemic
treatments for brain metastases prior to enrollment; by investigator assessment be
considered stable with no new signs or symptoms for at least 1 month, and on a stable
dose of steroids (unchanged for three weeks prior to registration or on a steroid
tapering regimen).
Patients with Recurrent or Refractory Brain Tumors
• At least 1 measurable lesion with longest diameter of at least 10 mm on any imaging
sequence.
• Patients with previously known neurological deficits must be clinically stable at time
of enrollment and able to complete all study related procedures. Patients with
documented or newly diagnosed neurological deficits will be enrolled at the
investigator's discretion.
• If patient receives steroids for neurological symptom control, the dose must be stable
(unchanged for three weeks prior to registration) or on a steroid tapering regimen.
Initiation of steroids per routine care immediately prior to CLR 131 dosing is
acceptable.
Exclusion Criteria:
• Patients receiving active treatment for central nervous system metastases or those
that are likely to require active treatment during anticipated participation in this
trial. Patients with stable brain metastases treated with steroids may enroll at the
investigator's discretion
• For solid tumor and lymphoma patients only, central nervous system involvement unless
previously treated with surgery, systemic therapy, or radiotherapy with the patient
neurologically stable. Patients with metastatic brain tumors that have been previously
treated are allowed, provided the patient is neurologically stable (determined at the
investigator's discretion).
• Antitumor therapy or investigational therapy, within 2 weeks of dosing. For certain
types of radiation (craniospinal, total abdominal, whole lung [spot irradiation to
skull-based metastases is not considered craniospinal radiation for the purposes of
this study]), at least 3 months must have elapsed. No washout is required for
palliative focal radiation. NOTE: Patients participating in non-interventional
clinical trials (i.e., non-drug) are allowed to participate in this trial
• Patients previously treated with iodine-131 (131I)-MIBG who have already received a
cumulative I-131 dose > 54 mCi/kg or who would exceed 54 mCi/kg by participating in
this trial, are not eligible.
Long-term Follow-up Study of Patients Receiving Onasemnogene Abeparvovec-xioi
This is a long-term follow-up safety and efficacy study of participants in clinical trials
for spinal muscular atrophy (SMA) who were treated with onasemnogene abeparvovec-xioi.
Participants will roll over from their respective previous (parent) study into this long-term
study for continuous monitoring of safety as well as monitoring of continued efficacy and
durability of response to onasemnogene abeparvovec-xioi treatment.
Jennifer Kwon, MD
All
Not specified
Phase 3
This study is NOT accepting healthy volunteers
NCT04042025
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Inclusion Criteria:
• Any participant with SMA who received onasemnogene abeparvovec-xioi gene replacement
therapy in a Novartis Gene Therapies-sponsored clinical study
• Participant/parent/legal guardian willing and able to complete the informed consent
process and comply with study procedures and visit schedule
Exclusion Criteria:
• Parent/legal guardian unable or unwilling to participate in the long-term follow-up
safety study
Spinal Muscular Atrophy Type I, Spinal Muscular Atrophy Type II, Spinal Muscular Atrophy Type III, SMA, Spinal muscular atrophy, Other, Congenital & Chromosomal Abnormalities
The APOLLO study is being done in an attempt to improve outcomes after kidney transplantation
and to improve the safety of living kidney donation based upon variation in the
apolipoprotein L1 gene (APOL1). Genes control what is inherited from a family, such as eye
color or blood type. Variation in APOL1 can cause kidney disease. African Americans,
Afro-Caribbeans, Hispanic Blacks, and Africans are more likely to have the APOL1 gene
variants that cause kidney disease. APOLLO will test DNA from kidney donors and recipients of
kidney transplants for APOL1 to determine effects on kidney transplant-related outcomes.
Brad Astor, PhD, MPH
All
Not specified
NA
This study is NOT accepting healthy volunteers
NCT03615235
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Inclusion Criteria for Living Donors:
• Living kidney donors with self-reported recent African ancestry (defined as African
American, Afro-Caribbean, Hispanic black or African) will be eligible for inclusion.
Exclusion Criteria for Living Donors:
• Participants who are unable or unwilling to provide informed consent.
Enrollment and bio sample collection from deceased donors at OPOs ended on May 31, 2023 and
recruiting kidney transplant recipients ended on June 15, 2023.
Phase II started on 9/1/2023 and only Living Donors will be recruited for an additional 2
years.
Kidney Diseases, Kidney Failure, Kidney Disease, Chronic, Other
The mission of the SARP is to improve the understanding of severe asthma through integrated
study of its clinical and biological features and to evaluate their changes over time. The
ultimate goal of these efforts is to promote better treatments for severe asthma.
Loren Denlinger, MD, PhD
All
6 Years and over
N/A
This study is also accepting healthy volunteers
NCT01606826
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Asthmatic Patients:
Inclusion Criteria:
1. Physician diagnosis of asthma,
2. Age 6 years and older
3. Evidence of historical reversibility, including either:
• FEV1 bronchodilator reversibility ≥ 12%, or
• Airway hyperresponsiveness reflected by a methacholine PC20 ≤16 mg/mL.
Exclusion Criteria:
1. Pregnancy during the characterization phase,
2. Current smoking,
3. Smoking history > 10 pack years if ≥30 years of age, or smoking history > 5 pack years
if <30 years of age (Note: if a subject has a smoking history, no smoking within the
past year),
4. Other chronic pulmonary disorders associated with asthma-like symptoms, including (but
not limited to) cystic fibrosis, chronic obstructive pulmonary disease, chronic
bronchitis, vocal cord dysfunction (that is the sole cause of respiratory symptoms and
at the PI's discretion), severe scoliosis or chest wall deformities that affect lung
function, or congenital disorders of the lungs or airways,
5. History of premature birth before 35 weeks gestation,
6. Unwillingness to receive an intramuscular triamcinolone acetonide injection,
7. Evidence that the participant or family may be unreliable or poorly adherent to their
asthma treatment or study procedures,
8. Planning to relocate from the clinical center area before study completion,
9. Any other criteria that place the subject at unnecessary risk according to the
judgment of the Principal Investigator and/or attending physician(s) of record, or
10. Currently participating in an investigational drug trial for asthma therapies.
Healthy Controls:
Inclusion criteria: Healthy subjects between the age of 18 and 65 years. Exclusion criteria
1. History of chronic diseases that affect the lungs,
2. A history suggestive of allergic rhinitis, eczema or chronic sinusitis,
3. An improvement in FEV1 of more than 12% following 4 puffs of albuterol,
4. Smoking history > 10 pack years if ≥30 years of age, or smoking history > 5 pack years
if <30 years of age, or any smoking within the past year,
5. Respiratory tract infection within the past 4 weeks,
6. Pregnancy,
7. History of premature birth (<35 weeks).
Immunotherapy With Nivolumab and Ipilimumab Followed by Nivolumab or Nivolumab With Cabozantinib for Patients With Advanced Kidney Cancer, The PDIGREE Study
This phase III trial compares the usual treatment (treatment with ipilimumab and nivolumab
followed by nivolumab alone) to treatment with ipilimumab and nivolumab, followed by
nivolumab with cabozantinib in patients with untreated renal cell carcinoma that has spread
to other parts of the body. The addition of cabozantinib to the usual treatment may make it
work better. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may
help the body's immune system attack the cancer, and may interfere with the ability of tumor
cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of
the enzymes needed for cell growth. It is not yet known how well the combination of
cabozantinib and nivolumab after initial treatment with ipilimumab and nivolumab works in
treating patients with renal cell cancer that has spread to other parts of the body.
Hamid Emamekhoo, M.D.
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03793166
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Inclusion Criteria:
• STEP I REGISTRATION CRITERIA
• Histologically documented renal cell carcinoma with clear cell component, including
patients who have sarcomatoid or rhabdoid features
• Any metastatic disease, including visceral, lymph node, other soft tissue and bone,
measurable per RECIST 1.1.
• Measurable disease as defined in the protocol.
• Must be intermediate or poor risk patient per International Metastatic Renal Cell
Carcinoma Database (IMDC) criteria (1 or more of the following): Karnofsky performance
status [KPS] < 80, < 1 year from diagnosis [including initial nephrectomy] to systemic
treatment for metastatic disease, hemoglobin less than lower limit of normal [LLN],
corrected calcium concentration greater than upper limit of normal [ULN], absolute
neutrophil count greater than ULN, platelet count > ULN).
• Central nervous system (CNS) disease permitted, if stable and not otherwise causing
symptoms or needing active treatment.
• Karnofsky performance status >= 70%.
• No prior treatment with PD-1, PD-L1, or CTLA-4 targeting agents (including but not
limited to nivolumab, pembrolizumab, pidilizumab, durvalumab, atezolizumab,
tremelimumab, and ipilimumab), or any other drug or antibody specifically targeting
T-cell co-stimulation or checkpoint pathways. The only exception is for prior
treatment with nivolumab or other PD-1/PD-L1/CTLA-4 targeting therapy on pre- or
post-operative trials, as long as > 1 year since completion of systemic therapy.
• No prior previous systemic therapy for renal cell carcinoma (prior HD IL-2 [> 28 days]
and prior adjuvant sunitinib > 180 days since completion and prior immunotherapy as
above are allowed).
• No systemic cancer therapy less than 28 days prior to registration; no radiation
therapy less than 14 days prior to registration. There must be a complete recovery and
no ongoing complications from radiotherapy.
• Not pregnant and not nursing, because this study involves an agent that has known
genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing
potential only, a negative serum or urine pregnancy test done =< 14 days prior to
registration is required.
• Age >= 18 years
• Absolute neutrophil count (ANC) >= 1,500/mm^3.
• Platelet count >= 100,000/mm^3.
• Hemoglobin >= 8 g/dL.
• Calculated (Calc.) creatinine clearance >= 30 mL/min.
• Urine protein =< 1+ or urine protein to creatinine (UPC) ratio < 1.
• Total bilirubin =< 1.5 x upper limit of normal (ULN) (except for patients with known
or likely Gilbert's syndrome, for whom total bilirubin up to 3 mg/dL is allowed with
direct bilirubin =< 20% total bilirubin)
• Aspartate aminotransferase/alanine aminotransferase (AST/ALT) =< 2.5 x upper limit of
normal (ULN) or < 5 x ULN if hepatic metastases present.
• STEP 2 REGISTRATION ELIGIBILITY CRITERIA
• Successful completion of at least 1 cycle of ipilimumab/nivolumab.
• Resolution of any treatment-related adverse events to grade 1 or less per dose
modification section (this criteria does not include any adverse events [AEs] not
attributable to treatment which are present due to disease), with
prednisone-equivalent dosing at 10 mg daily or less. Exceptions for this criteria
include patients receiving replacement hormone treatments (such as levothyroxine for
treatment-related hypothyroidism or glucocorticoid replacement for adrenal
insufficiency). Please contact study chair if further discussion is needed.
• No more than 80 days from last dose of ipilimumab/nivolumab.
Exclusion Criteria:
• Active autoimmune disease requiring ongoing therapy.
• Ongoing acute toxicity > grade 2 from previous treatment.
• History of severe allergic, anaphylactic or other hypersensitivity reactions to
chimeric or humanized antibodies.
• Active hepatitis B/C, or active tuberculosis (PPD response without active TB is
allowed)
• Human immunodeficiency virus (HIV) -infected patients with detectable viral load
within 6 months prior to registration. Patients on effective anti-retroviral therapy
with undetectable viral load within 6 months prior to registration are eligible.
• Concurrent use of immunosuppressive medication including prednisone above 10 mg daily.
• Uncontrolled adrenal insufficiency.
• Uncontrolled hypertension (systolic blood pressure [BP] >150 mmHg or diastolic BP > 90
mmHg).
• Major surgery less than 28 days prior to registration.
• Any serious non-healing wound, ulcer, or bone fracture within 28 days prior to
registration.
• Any arterial thrombotic events within 180 days prior to registration.
• Clinically significant hematuria, hematemesis, or hemoptysis within 12 weeks prior to
registration.
• Cavitating pulmonary lesions or known endotracheal or endobronchial disease
manifestations.
• Lesions encasing or invading any major blood vessels (this does not include tumor
thrombus extending into/through renal vein/inferior vena cava [IVC]). Patients with
tumor thrombus extending into/through renal vein are considered eligible.
• Moderate of severe hepatic impairment (Child-Pugh B or C).
• Any history of untreated pulmonary embolism or deep venous thrombosis (DVT) in the 180
days prior to registration. (Any asymptomatic, treated pulmonary embolism or
asymptomatic, treated deep venous thrombosis > 30 days prior to registration allowed).
• Corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms.
• Unstable cardiac arrhythmia within 6 months prior to registration.
• Any gastrointestinal (GI) bleeding =< 180 days, hemoptysis, or other signs of
pulmonary hemorrhage =< 90 days prior to registration.
• History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess,
bowel obstruction, or gastric outlet obstruction within 180 days prior to
registration.
• Active peptic ulcer disease, inflammatory bowel disease, or malabsorption syndrome
within 28 days prior to registration.
• Untreated hypothyroidism (treated hypothyroidism on thyroid replacement therapy is
allowed. Abnormal thyroid-stimulating hormone (TSH) is acceptable with normal T3/free
T4 if treated on thyroid replacement therapy)
• Evidence of pancreatitis, history of organ transplant, or history of congenital QT
syndrome.
• Active treatment with coumarin agents (e.g., warfarin), direct thrombin inhibitors
(e.g., dabigatran), direct Xa inhibitor betrixaban or platelet inhibitors (e.g.,
clopidogrel) within 5 days of registration. Allowed anticoagulants include:
prophylactic use of low-dose aspirin for cardio-protection (per local applicable
guidelines) and low-dose low molecular weight heparins (LMWH), therapeutic doses of
LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban,
apixaban. Allowed also in patients with known brain metastases who are on a stable
dose of the anticoagulant for at least 1 week prior to registration without clinically
significant hemorrhagic complications from the anticoagulation regimen or the tumor.
• Significant cardiac ischemia events (ST elevation myocardial infarction [STEMI] or
non-ST elevation myocardial infarction [NSTEMI]) within 6 months or active NY Heart
Association class 3-4 heart failure symptoms
Clear Cell Renal Cell Carcinoma, Metastatic Malignant Neoplasm in the Bone, Metastatic Malignant Neoplasm in the Lymph Nodes, Metastatic Malignant Neoplasm in the Soft Tissues, Metastatic Malignant Neoplasm in the Viscera, Sarcomatoid Renal Cell Carcinoma, Stage III Renal Cell Cancer AJCC v8, Stage IV Renal Cell Cancer AJCC v8, Kidney
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