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341 Study Matches
Determinants of Renal Structural Responses to Enzyme Replacement Therapy (ERT) in Fabry Disease Study (LDN6702)
The effect of enzyme replacement therapy on how well your kidneys are responding to enzyme replacement therapy (ERT) is not clear from blood and urine tests alone, but may be more clear in comparisons of kidney biopsies performed before and some time after ERT has been initiated, and this is what we are focusing our study efforts on. The purpose of this study is to obtain your permission to allow us to study the kidney biopsy tissues (collected for medical reasons) after the regular routine studies have been completed. Through our special research measurements and additional study, we hope to be able to see and measure very specific changes in the kidney tissues from Fabry patients taking ERT. We also hope that through these studies of what happens within the kidney before and after starting ERT, we are able to reveal valuable information about the importance of factors like your age that you started ERT, the amount or dosage of ERT, and any differences seen between males and females.
Michael Mauer
1205M14901
Inclusion Criteria:
• diagnosed with Fabry disease and a clinical decision has been made to obtain a kidney biopsy, a GFR, and urinary albumin studies
• have previously completed clinical trials which included measures of renal function and renal biopsies
Exclusion Criteria:
• serum creatinine more than 2.5 mg/dL
• known to have a renal disease other than Fabry
Kidney, Prostate & Urinary, Rare Diseases
Fabry disease, Kidney disease, Renal disease
Bone as Regulator of Energy Balance and Male Fertility after SCI: A Pilot Study (Osteocalcin Protocol)
This study proposes a cross-sectional case-control pilot study. Spinal Cord Injury (SCI) is associated with altered bone metabolism, male infertility, and increased rates of insulin resistance. The researchers will perform testing for 30 men with SCI and 10 without SCI. Data will be used to power subsequent clinical trials. A Fairview letter of support has also been uploaded.
Leslie Morse
STUDY00011054
Inclusion Criteria:
SCI Inclusion Criteria:
-Stated willingness to comply with all study procedures and availability for the duration of the study
-Male age 18-50
-Have completed inpatient rehabilitation and are living in the community
-Have motor complete SCI
Use a wheelchair as primary mobility mode
-English and non-English speakers
No SCI Inclusion Criteria:
-Stated willingness to comply with all study procedures and availability for the duration of the study
-Male age 18-50
-Able to ambulate independently
-English and non-English speakers
Exclusion Criteria:
SCI Exclusion Criteria:
-presence of other neurological condition
-use of chronic ventilator support
-metabolic bone disease
-thyroid disorder
-current use of medications potentially affecting bone health (including bisphosphonates (etidronate or didronel, clodronate or bonefos, tiludronate or skelid, pamidronate, or aredia, alendronate or fosamax, ibandronate or boniva, risedronate or actonel, zoledronate or reclast) parathyroid hormone (forteo, teriparatide, abaloparatide), denosumab (prolia), testosterone, estrogen, anti-epileptics (phenytoin or dilantin, phenobarbital, valproic acid or depakene) lithium, glucocorticoid use for more than 3 months, and those who have received inhaled glucocorticoids in the past year).
-Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
No SCI Exclusion Criteria:
-presence of neurological condition
-metabolic bone disease
-thyroid disorder
-current use of medications potentially affecting bone health (including bisphosphonates (etidronate or didronel, clodronate or bonefos, tiludronate or skelid, pamidronate, or aredia, alendronate or fosamax, ibandronate or boniva, risedronate or actonel, zoledronate or reclast) parathyroid hormone (forteo, teriparatide, abaloparatide), denosumab (prolia), testosterone, estrogen, anti-epileptics (phenytoin or dilantin, phenobarbital, valproic acid or depakene) lithium, glucocorticoid use for more than 3 months, and those who have received inhaled glucocorticoids in the past year).
-known history of or found on baseline testing to have osteoporosis.
-known history of or found on baseline testing to have diabetes.
-known history of or found on baseline testing to have infertility.
-Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data. Spinal Cord Injury
A Pilot Study of a Parenting Intervention for Parents of Adolescents with Non-Suicidal Self-Injury
University of Minnesota researchers are conducting a research study to learn more about how an individually-delivered parenting program may help teens with self-harm. Eligible parents will be assigned by chance (like flipping a coin) to one of two conditions: (1) Healthy Emotions and Relationships with Teens – A Guide for Parents (HEART-P): a 12-session individually-delivered parenting program that teaches parents skills and strategies to help them respond to their adolescents’ emotions, or (2) wait list: parents will be offered the opportunity to receive HEART-P following their completion of the assessments during the study phase.
Meredith Gunlicks-Stoessel
STUDY00017096
Inclusion Criteria:
• Age 12-17 years
• at least 3 episodes of non suicidal self injury with at least one episode occurring in the past 12 weeks
• receiving mental health treatment that doesn't include individually delivered treatment for the parent. This can be at any mental health clinic
• at least one parent or caregiver who is willing to participate -for parents/caregivers: able to speak and write English
Exclusion Criteria:
• history of a primary psychotic disorder
• neurodevelopmental disorder such as intellectual disability or autism
Children's Health, Mental Health & Addiction
anxiety, cutting, depression, non suicidal self injury, self-harm
A longitudinal study of imaging biomarkers in amyotrophic lateral sclerosis (ALS) and primary lateral sclerosis (PLS)
The purpose of the study is to test new biomarkers of amyotrophic lateral sclerosis (ALS) and primary lateral sclerosis (PLS) using MRI scans at 3 tesla (3T). Identifying biomarkers of a disease can lead to a better understanding of the disease as well as improved treatments.
David Walk
1306M35941
Inclusion Criteria:
• 21 to 75 years old
• diagnosis of possible, laboratory-supported probable, probable, or definite ALS or PLS
Exclusion Criteria:
• other neurodegenerative diseases (Parkinson disease, Alzheimer's disease, etc).
• inability to undergo MRI scanning
• needs assistance to walk or climb stairs
Brain & Nervous System, Rare Diseases
ALS, Amyotrophic Lateral Sclerosis, Primary Lateral Sclerosis
A PROSPECTIVE OBSERVATIONAL STUDY OF SOLID ORGAN TRANSPLANTATION UTILIZING HIV-POSITIVE DONORS IN HIV-POSITIVE RECIPIENTS
This is a prospective, observational study designed to evaluate the safety of solid organ transplantation using HIV-positive deceased donors (liver, kidney) and HIV-positive living donors (liver) in HIV-positive recipients.
Timothy Pruett
1608M93841
RECIPIENT ELIGIBILITY CRITERIA HIV-Positive Recipient Inclusion Criteria (liver, kidney)
Participant is able to understand and provide informed consent.
Participant meets standard listing criteria for transplant.
Documented HIV infection (by any licensed ELISA and confirmation by Western Blot, positive HIV ab IFA, or documented history of detectable HIV-1 RNA).
Participant is ≥ 18 years old.
No evidence of active opportunistic complications of HIV infection.
Participant CD4+ T-cell count is >/= 200/µL within 16 weeks prior to transplant for kidney transplant recipients. For liver transplant recipient, CD4+ T-cell counts need to be >/= 100/ul (or >/= 200/µL if history of opportunistic infection) within 16 weeks prior to transplant.
Participant most recent HIV-1 RNA < 50 copies/mL (by any FDA-approved assay performed in CLIA-approved laboratory), in the 26 weeks prior to transplant. Participants unable to tolerate ART due to organ failure or who have only recently started ART may have detectable viral load and still be considered eligible if the study team is confident there will be a safe, tolerable, and effective antiretroviral regimen once organ function is restored after transplantation.
Concurrence by the study team that based on medical history and ART, viral suppression can be achieved in the recipient post-transplant.
No history of primary CNS lymphoma or progressive PML.
On a stable antiretroviral regimen. Participants unable to tolerate ART due to organ failure may still be considered eligible if the study team is confident there will be a safe, tolerable, and effective antiretroviral regimen once organ function is restored after transplantation.
HIV-Positive Recipient Exclusion Criteria (liver, kidney)
• Participant has concomitant conditions that, in the judgment of the investigators, would preclude transplantation or immunosuppression. DONOR ELIGIBILITY CRITERIA HIV-Positive Deceased Donor (liver, kidney) Must meet all clinical criteria for HIV-uninfected organ donors. No evidence of invasive opportunistic complications of HIV infection. Pre-implant donor organ biopsy showing no disease process that would put the recipient at increased risk of rapid progression to end-stage organ failure, to be stored for the duration of the study. Donor has documented HIV infection (by any licensed ELISA and confirmation by Western Blot, positive HIV ab IFA, or history of detectable HIV-1 RNA) from a CLIA-approved laboratory. If known history of HIV infection and prior antiretroviral therapy, the study team must describe the anticipated post-transplant antiretroviral regimen to be prescribed for the recipient and justify its conclusion that the regimen will be safe, tolerable and effective. HIV-Positive Living Donor (liver) Donor meets all clinical criteria to be a living liver donor other than being HIV positive. Donor has documented HIV infection (by any licensed ELISA and confirmation by Western Blot, positive HIV ab IFA, or history of detectable HIV-1 RNA) from a CLIA-approved laboratory. No evidence of invasive opportunistic complications of HIV infection Donor CD4+ T-cell count is >/= 500/µL in the 26 weeks prior to donation. The most recent HIV-1 RNA has been below 50 copies RNA/ml in the 26 weeks prior to donation. On a stable antiretroviral regimen. Must be evaluated by the HIV/Transplant Infectious Diseases team to verify resistance history and current ART regimens. The potential for transmission of resistant strain of HIV will be assessed. Pre-implant donor liver biopsy to be stored for the duration of the study showing no evidence of a disease process that would put the donor at increased risk of progressing to end-stage organ failure after donation, or that would present a risk of poor graft function to the recipient. Must be evaluated by an independent HIV study living donor advocate separate from the transplant service in addition to the living donor advocate seen by all living donors.
• Participant has concomitant conditions that, in the judgment of the investigators, would preclude transplantation or immunosuppression. DONOR ELIGIBILITY CRITERIA HIV-Positive Deceased Donor (liver, kidney) Must meet all clinical criteria for HIV-uninfected organ donors. No evidence of invasive opportunistic complications of HIV infection. Pre-implant donor organ biopsy showing no disease process that would put the recipient at increased risk of rapid progression to end-stage organ failure, to be stored for the duration of the study. Donor has documented HIV infection (by any licensed ELISA and confirmation by Western Blot, positive HIV ab IFA, or history of detectable HIV-1 RNA) from a CLIA-approved laboratory. If known history of HIV infection and prior antiretroviral therapy, the study team must describe the anticipated post-transplant antiretroviral regimen to be prescribed for the recipient and justify its conclusion that the regimen will be safe, tolerable and effective. HIV-Positive Living Donor (liver) Donor meets all clinical criteria to be a living liver donor other than being HIV positive. Donor has documented HIV infection (by any licensed ELISA and confirmation by Western Blot, positive HIV ab IFA, or history of detectable HIV-1 RNA) from a CLIA-approved laboratory. No evidence of invasive opportunistic complications of HIV infection Donor CD4+ T-cell count is >/= 500/µL in the 26 weeks prior to donation. The most recent HIV-1 RNA has been below 50 copies RNA/ml in the 26 weeks prior to donation. On a stable antiretroviral regimen. Must be evaluated by the HIV/Transplant Infectious Diseases team to verify resistance history and current ART regimens. The potential for transmission of resistant strain of HIV will be assessed. Pre-implant donor liver biopsy to be stored for the duration of the study showing no evidence of a disease process that would put the donor at increased risk of progressing to end-stage organ failure after donation, or that would present a risk of poor graft function to the recipient. Must be evaluated by an independent HIV study living donor advocate separate from the transplant service in addition to the living donor advocate seen by all living donors.
Clinics and Surgery Center (CSC)
Frailty Assessment by Edmonton Frail Scale to Predict Outcome in Patients Undergoing Cardiovascular Surgery "Frail Heart" Study
We are looking at measures of frailty (including an assessment questionnaire and other data from the medical record) and the relationship to outcomes from cardiac or vascular surgery. The questionnaire will take about 10 minutes to complete and we will contact you by phone once every three months for one year after your surgery.
Tjorvi Perry
STUDY00009831
Inclusion Criteria:
People who are having any of the following heart surgery procedures:
• thoracic aortic surgery
• coronary artery bypass graft surgery
• Aortic valve replacement
• Mitral valve replacement or repair
• Tricuspid valve replacement or repair
• Pulmonary valve replacement
• Infective endocarditis surgery
• Open and interventional abdominal aortic revascularization
Exclusion Criteria:
• People who have liver cirrhosis
• People who aren't able to make independent health care decisions
Heart & Vascular
Cardiac Surgery, Coronary Artery Bypass, Heart Valve Replacement, Abdominal Aortic Surgery
Pilot study to determine safety of lower extremity injection of agitated saline for echocardiography of the heart.
Prospective study to compare safety of upper versus lower extremity injection agitated saline (bubble study) using echocardiography of the heart.
Carmelo Panetta
STUDY00016117
Inclusion Criteria:
• 18 years or older
• "bubble study" i.e. echocardiography with agitated saline injection ordered
Exclusion Criteria:
• enrolled in another drug or medical device study within 30 days of study enrollment.
• liver failure in past 6 months
Heart & Vascular
Echocardiogram, PFO
A Prospective Study of Acute Flaccid Myelitis (AFM) to Define Natural History, Risk Factors, and Pathogenetic Mechanisms
The overall objective of the study is to create a biorepository of specimens and associated clinical and outcome data for use in future studies of AFM, including virologic or immunologic assessments.
Mark Schleiss
STUDY00008961
Inclusion Criteria:
• Experiencing flaccid limb weakness involving one or more limbs with diagnosis of suspected Acute Flaccid Myelitis (AFM)
• Weakness started less than 30 days ago
• Child weighs at least 7.8 kg
• Had or will have a MRI of the spinal cord
• For " Healthy Household Comparators": lived in the same home as the child who is thought to have AFM (within the past 30 days) and weight at least 6.0 kg
Exclusion Criteria:
• Known condition other than AFM causing the flaccid limb weakness
Bone, Joint & Muscle, Rare Diseases
Acute Flaccid Myelitis (AFM)
A MULTI-CENTER STUDY OF NON-INVASIVE COLORECTAL CANCER EVALUATION IN CYSTIC FIBROSIS (NICE-CF) (NICE-CF)
We are comparing the results of stool sample testing to colonoscopy for people who have Cystic Fibrosis (CF). We want to find out how effective stool sample testing is in detecting adenomas, including colorectal cancer.
Shahnaz Sultan
STUDY00015837
Inclusion Criteria:
• Ages 18 - 75 years of age without history of transplant, or adults with CF age 18 - 75 who have had a transplant
• Diagnosis of Cystic Fibrosis with a sweat chloride test result of at least 60 mmol/L and/or documented CF-causing CFTR mutations and clinical
• Speak and write English or Spanish
• Having a screening or surveillance colonoscopy for colorectal cancer (CRC)
Exclusion Criteria:
• Women who are pregnant
• Active inflammatory bowel disease (Crohns Disease or Ulcerative Colitis)
• History of colon cancer diagnosis and treatment within 5 years of enrollment
• Symptoms that indicate colonoscopy is for diagnostic purposes rather than as screening for CRC
Digestive & Liver Health, Rare Diseases
Clinics and Surgery Center (CSC), colon cancer screening, cystic fibrosis
A T Cell phenotype signature driven dose finding study with siplizumab in type 1 diabetes mellitus (TN28)
This is a study looking at people aged 8-45 years old with recent onset of T1D (within 18 months) to find a safe dose regimen of siplizumab.
Antoinette Moran
STUDY00017694
Inclusion Criteria:
• age 8 to 45
• at least two or more diabetes-related biochemical autoantibodies
• for participants under 18 years old, weight greater than the 5th percentile and less than 95th percentile for age and sex
• for participants 18 or older, BMI at least 15, no more than 30
• ADA Stage 2 criteria at least one high-risk markers (study staff will review)
• blood pressure
Exclusion Criteria:
• deficiency of the immune system
• pregnant (or anticipate becoming pregnant) or breast feeding
• active infection
• taking immunosuppressive agents including chronic use of systemic steroids
• any acute or chronic illness (study staff will review)
Children's Health, Diabetes & Endocrine
T1D, Diabetes, Trial Net, Type 1 diabetes
A Randomized, Comparative Effectiveness Study of Staged Complete Revascularization with Percutaneous Coronary Intervention to Treat Coronary Artery Disease vs Medical Management Alone in Patients with Symptomatic Aortic Valve Stenosis undergoing Elective Transfemoral Transcatheter Aortic Valve Replacement: The COMPLETE TAVR Study (COMPLETE TAVR)
The study will be a randomized, multicenter, open-label trial with blinded adjudication of outcomes.
Greg Helmer
STUDY00012707
Inclusion Criteria:
Men and women with severe symptomatic aortic valve stenosis defined as: [aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2] AND [Jet velocity ≥ 4.0 m/s or mean gradient ≥ 40 mmHg] AND [NYHA Functional Class ≥ 2 OR abnormal exercise test with severe SOB, abnormal blood pressure response, or arrhythmia]
AND
Coronary artery disease defined as: (at least 1 coronary artery lesion of ≥70% visual angiographic diameter stenosis in a native segment that is at least 2.5 mm in diameter that is not a CTO and is amenable to treatment with percutaneous coronary intervention (PCI))
AND
Consensus by the Multidisciplinary Heart Team that the patient is suitable for elective transfemoral transcatheter aortic valve replacement (TAVR) with a balloon expandable transcatheter heart valve AND would receive a bypass with an anastomosis distal to the coronary artery lesion(s) if they were undergoing surgical aortic valve replacement.
AND
Successful TAVR defined as the implantation of a single transcatheter aortic valve within the past 96 hours with freedom from more than minimal aortic insufficiency, stroke, or major vascular complications
Exclusion Criteria:
PCI already performed within 90 days prior to TAVR or at the same time as the index transfemoral TAVR procedure
Planned PCI of coronary artery lesion(s)
Planned surgical revascularization of coronary artery lesion(s)
Non-cardiovascular co-morbidity reducing life expectancy to < 5 years
Any factor precluding 5-year follow-up
Prior coronary artery bypass grafting surgery or surgical valve replacement
Severe mitral regurgitation (> 3+)
Severe left ventricular dysfunction (LVEF < 30%)
Low coronary takeoff (high risk for coronary obstruction)
Acute myocardial infarction within 90 days
Stroke or transient ischemic attack within 90 days
Renal insufficiency (eGFR < 30 ml/min) and/or renal replacement Rx
Hemodynamic or respiratory instability Clinics and Surgery Center (CSC)
Clinical, Electrocardiographic, and Cardiac Magnetic Resonance Imaging Risk Factors Associated with Ventricular Tachyarrhythmias in Nonischemic Cardiomyopathy (MARVEN Study)
The specific aims of the trial are to prospectively study nonischemic cardiomyopathy patients qualified for CRT-D following currently approved standard indications in order to: 1) Validate the MADIT-CRT-derived model predicting fast VT/VF in nonischemic cardiomyopathy patients with QRS≥120 ms. 2) Determine whether CMR added to the risk model validated in specific aim 1 will further improve risk stratification for predicting fast VT/VF in nonischemic cardiomyopathy patients with QRS≥120ms. 3) Evaluate costs of risk stratification using Holter and CMR in relationship to costs of implanted devices without risk stratification.
Chetan Shenoy
STUDY00007420
Inclusion Criteria:
• At least 21 years of age
• Diagnosed with nonischemic dilated cardiomyopathy (NICM)
• On optimal medications for management
• If a cardiac defibrillator hasn't been implanted, must be willing to have a cardiac defibrillator implanted within 3 months of study enrollment
• If a cardiac defibrillator has been implanted, it must be more recent that July 1, 2018
Exclusion Criteria:
• Nonischemic cardiomyopathy due to other known causes including amyloidosis, sarcoidosis, cardiotoxicity due to chemotherapy, hypertrophic cardiomyopathy,
• History of prior myocardial infarction, percutaneous coronary intervention, or coronary bypass grafting
• History of ablation to treat ventricular fibrillation
Heart & Vascular
Implantable cardioverter defibrillator (ICD), Nonischemic dilated cardiomyopathy (NICM), Clinics and Surgery Center (CSC)
Testing Effective Methods to Recruit Sexual and Gender Minority Cancer Patients for Cancer Studies: Aim 1 SGM Interviews
In Aim 1, we will document, in depth, SGM’s attitudes towards participating in NIH cancer research, identifying the facilitators and barriers that each group reports influences their willingness to participate. We will also investigate any impact poor cancer care and discrimination has on research participation. We will investigate these in cisgender SM men, cisgender SM women and gender minority cancer patients (n=15 per group) and compare experiences within these small populations and between SGM and a cisgender, heterosexual patient comparison group
B R Simon Rosser
STUDY00016416
Inclusion Criteria:
• people who identify as LGBT
• at least 18 years of age
• currently living in the US
• diagnosed with and treated for cancer.
• speak English
Exclusion Criteria:
• people who have been diagnosed with cancer but haven't been treated
Cancer, Community Health
Cancer, LBGT
Sightline: Determination and Validation of Lung EpiCheck a Multianalyte Assay for Lung Cancer Prediction. A Case-Control Study.
This is a prospective, case-control, multi-center, observational nonsignificant risk study. The study includes two phases: Lung EpiCheck assay development and clinical validation. Samples collected under this protocol will support both phases. The study includes two subject groups: a Cases Series and a Screening Series.
Abbie Begnaud
STUDY00016467
Inclusion Criteria:
• Current or past smokers, with at least 20 pack-years
• People who have with either a high suspicion for lung cancer, with surgery planned for biopsy or removal
• People who have lung cancer that hasn't been treated yet
Exclusion Criteria:
• People who have diagnosis or treatment of any previous cancer, including lung cancer, in the past 5 years, except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix
• Current lung cancer is known to be stage III or IV by pathology.
• People having regular screening to monitor a lung nodule
Cancer, Respiratory System
Lung Cancer, Lung Cancer Screening, Clinics and Surgery Center (CSC)
A Phase 2, Open-Label, Basket Study of Atrasentan in Patients with Proteinuric Glomerular Diseases (AFFINITY)
The purpose of the research is to find out if atrasentan delays worsening of kidney function in IgAN, FSGS, and Alport Syndrome.
Michelle Rheault
STUDY00012146
Inclusion Criteria:
• Age 18 years and older for patients in the IgAN, FSGS, and Alport Syndrome cohorts
• age 18-70 years for patients in the DKD cohort
• receiving a maximally tolerated dose of RAS inhibitor therapy (ACEi or ARB) that has been stable for at least 12 weeks
• there are different requirements for each diagnosis category & study staff will review these
Exclusion Criteria:
• current diagnosis of another cause of chronic kidney disease or another primary glomerulopathy
• history of kidney transplantation or other organ transplantation
• except for FSGS patients, use of systemic immunosuppressant medications, such as steroids, for more than 2 weeks in the past 3 months
• blood pressure above 150 mmHg systolic or 95 mmHg diastolic
• history of heart failure or a previous hospital admission for fluid overload.
• history of liver disease
• hemoglobin below 9 g/dL or blood transfusion for anemia within the past 3 months.
• cancer in the past 5 years (except nonmelanoma skin cancer and curatively treated cervical carcinoma in situ)
• women who are pregnant, breastfeeding, or intend become pregnant during the study
• recently received an investigational agent -clinically significant unstable or uncontrolled medical condition (study staff will review)
Kidney, Prostate & Urinary
Glomerular Disease, Alport Syndrome, IgAN, FSGS, Proteinuric Glomerular Diseases
COG ACNS1422 - A Phase 2 Study of Reduced Therapy for Newly Diagnosed Average-Risk WNT-Driven Medulloblastoma Patients
Patients greater than or equal to 3 years of age and < 22 years of age with newly diagnosed type of brain tumor called WNT)/Wingless (WNT)-driven medulloblastoma using reduced craniospinal radiotherapy.
Christopher Moertel, MD
STUDY00002501
Inclusion Criteria:
Patients must be greater than or equal to 3 years and less than 22 years of age at the time of enrollment
Patients must be newly diagnosed and have:
Eligibility confirmed by rapid central pathology and molecular screening review on APEC14B1 and via the Molecular Characterization Initiative:
Classical histologic type (non LC/A) WNT medulloblastoma
Positive nuclear beta-catenin by immunohistochemistry (IHC)
Positive for CTNNB1 mutation
Negative for MYC and MYCN by fluorescence in situ hybridization (FISH)
Patient must have negative lumbar cerebrospinal fluid (CSF) cytology
Note: CSF cytology for staging should be performed no sooner than 14 days post operatively to avoid false positive CSF; ideally, CSF should be obtained between day 14 and day 21 to allow for final staging status before enrollment onto the study; patients with positive CSF cytology obtained 0 to 14 days after surgery should have cytology repeated to determine eligibility and final CSF status; patients with negative CSF cytology from lumbar puncture obtained 0 to 14 days after surgery do not need cytology repeated; patients with negative CSF cytology from lumbar puncture obtained prior to surgery do not need cytology repeated post-operatively
Patients must have eligibility confirmed by Rapid Central Imaging Review on APEC14B1; patients must have =< 1.5 cm^2 maximal cross-sectional area of residual tumor; whole brain magnetic resonance imaging (MRI) with and without gadolinium and spine MRI with gadolinium must be performed
Patients must be enrolled, and protocol therapy must be projected to begin, no later than 36 days after definitive diagnostic surgery (day 0)
Peripheral absolute neutrophil count (ANC) >= 1000/uL
Platelet count >= 100,000/uL (transfusion independent)
Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions)
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:
3 to < 6 years of age: maximum (max) serum creatinine 0.8 mg/dL (males and females)
6 to < 10 years of age: max serum creatinine 1 mg/dL (males and females)
10 to < 13 years of age: max serum creatinine 1.2 mg/dL (males and females)
13 to < 16 years of age: max serum creatinine 1.5 md/dL (males) and 1.4 md/dL (females)
>= 16 years of age: max serum creatinine 1.7 mg/dL (males) and 1.4 mg/dL (females)
The threshold creatinine values were derived from the Schwartz formula for estimating GFR utilizing child length and stature data published by the Centers for Disease Control and Prevention (CDC)
Total or direct bilirubin =< 1.5 x upper limit of normal (ULN) for age, and
Serum glutamate pyruvate (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L (3x ULN); for the purpose of this study, the ULN for SGPT is 45 U/L
Central nervous system function defined as:
Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled
Patients must not be in status epilepticus, a coma or on assisted ventilation at the time of study enrollment
Patients must have receptive and expressive language skills in English, French, or Spanish to complete the QoL and neurocognitive assessments; if a patient meets these criteria but the parent/guardian speaks a language other than English, French, or Spanish, the patient may still be enrolled and tested, and the parent-report measures should be omitted
All patients and/or their parents or legal guardians must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
Patients with metastatic disease by either MRI evaluation (brain and spine) or lumbar CSF cytology are not eligible; patients who are unable to undergo a lumbar puncture for assessment of CSF cytology are ineligible
Patients must not have received any prior radiation therapy or chemotherapy (tumor-directed therapy) other than surgical intervention and/or corticosteroids
Pregnancy and Breast Feeding
Female patients who are pregnant are ineligible due to risks of fetal and teratogenic adverse events as seen in animal/human studies
Lactating females are not eligible unless they have agreed not to breastfeed their infants
Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation
Patients with a history of moderate to profound intellectual disability (i.e., intelligence quotient [Q)]=< 55) are not eligible for enrollment; PLEASE NOTE: Children with a prior history of attention deficit hyperactivity disorder (ADHD) or a specific learning disability (e.g., dyslexia) are eligible for this study. Children with posterior fossa syndrome (also known as cerebellar mutism) are eligible for this studyStudy of Nutraceutical Intervention with High Phenolic Extra Virgin Olive Oil and Curcumin for Neurofibromatosis, type 1 (NF1)
This is a single center, open label, Phase I clinical trial of bioactive curcumin with high phenolic extra virgin olive oil (HP-EVOO) to treat cutaneous neurofibromas (cNF) in Neurofibromatosis, type 1 (NF1) patients (aged 18 years or older).
Christopher Moertel, MD
STUDY00014832
Inclusion Criteria:
• clinical diagnosis of Neurofibromatosis type 1 and/or genetic testing
• measurable skin neurofibromas
Exclusion Criteria:
• treatment with selumetinib or other MAPK, MEK or mTOR inhibitors, other targeted therapies, chemotherapy or radiation (study staff will review)
• swallowing difficulties or strong gag reflex that make it difficult to take study treatment
• supplement with high phenolic olive oil or curcumin within six months
• women who are pregnant or anticipate becoming pregnant
• history of other physical or mental health issues (study staff will review)
Rare Diseases
Dietary Supplement: curcumin, high phenolic extra virgin olive oil, Neurofibromatosis, Type 1 (NF1)
MAYFLOWERS-0B-20: A Prospective Study Evaluating Maternal and FetaL Outcomes in the ERa of ModulatorS (MAYFLOWERS) (MAYFLOWERS)
This is a prospective, multi-center, observational study in pregnant women with cystic fibrosis (CF) to characterize forced expiratory volume in 1 second (FEV1) changes based on exposure to highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators. The key factors contributing to the change in lung function during pregnancy and for 2 years post-delivery will be evaluated along with assessment of fetal and maternal outcomes.
Joanne Billings
STUDY00012925
Inclusion Criteria:
Pregnant, intending to continue pregnancy, enrolled in the Cystic Fibrosis Foundation Patient Registry (CFFPR)
Exclusion Criteria:
None Clinics and Surgery Center (CSC)
A Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants with Advanced Cancer (TRIO049)
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer.
Boris Winterhoff
STUDY00014893
Inclusion Criteria:
Advanced solid tumor
Measurable disease, per RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Adequate organ function
Exclusion Criteria:
Has not recovered [recovery is defined as NCI CTCAE, version 5.0, grade ≤1] from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements
Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 14 days with small molecule and within 28 days with biologic before the first dose of TORL-1-23
Progressive or symptomatic brain metastases
Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection
History of significant cardiac disease
History of myelodysplastic syndrome (MDS) or AML
History of another cancer within 3 years before Day 1 of study treatment, with the exception of basal or squamous cell carcinoma of the skin that has been definitively treated. A history of other malignancies with a low risk of recurrence, including appropriately treated ductal carcinoma in situ (DCIS) of the breast and prostate cancer with a Gleason score less than or equal to 6, are also not excluded
If female, is pregnant or breastfeeding Clinics and Surgery Center (CSC)
A Phase 1/2 Study of [225Ac]-FPI-1434 Injection in Patients with Locally Advanced or Metastatic Solid Tumours
This is an early study of a new drug, called [225Ac]-FPI-1434, to treat solid tumors that have not responded to usual treatment. We are testing different doses of the drug and looking at how well it works for treating the cancer and side effects that occur.
Douglas Yee, MD
STUDY00013618
Inclusion Criteria:
Pathologically documented, definitively diagnosed, advanced solid tumour that is refractory to all standard treatment, for which no standard treatment is available, or it is contraindicated, or the patient refuses standard therapy.
Measurable or evaluable disease in accordance with RECIST 1.1.
Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
Life expectancy of greater than 3 months as judged by the treating physician.
Available tumour tissue (either archival or fresh biopsy) for IGF-1R immunohistochemistry. Submission of the tissue is not required prior to enrollment.
Adequate heart, kidney, and liver function
Adequate bone marrow reserves
Ability to understand and the willingness to sign a written informed consent document.
Phase 2 Specific
Histologically and/or cytologically documented diagnosis of locally advanced, inoperable, metastatic, or recurrent solid tumour types: endometrial, cervical, ovarian, TNBC, HER 2-negative breast, HNSCC, ACC, or uveal melanoma.
Have measurable disease per RECIST 1.1 Failure to respond to standard systemic therapy, or for whom standard or curative systemic therapy does not exist or is not tolerable.
Imaging Eligibility
Prior to the initial [225Ac]-FPI-1434 cycle: Sufficient target expression in at least 1 lesion following [111In]-FPI-1547 and SPECT imaging.
Exclusion Criteria:
Systemic therapeutic radiopharmaceutical within 6 months prior to enrollment into this study.
Contraindications to or inability to perform the required imaging procedures in this study (e.g., inability to lay flat during scan time)
Uncontrolled brain metastasis, including but not limited to the need for treatment with steroids, surgery or radiation therapy.
Anticancer therapy (including investigational agents) or external beam radiation therapy within 14 days of the dosing of [111In]-FPI-1547
Has known additional malignancy that is progressing or has required active treatment within the past 3 years. Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (e.g., breast cancer, cervical cancer, prostate) that have undergone potentially curative therapy are not excluded.
Residual CTCAE ≥ Grade 2 side effects of prior therapy, with the exception of residual grade 2 alopecia.
Prior organ transplantation, including stem cell transplantation.
Any prior treatment with nitrosoureas or actinomycin-D.
Clinically relevant levels of protein in the urine
Known or suspected allergies or contraindications to the Investigational Products or any component of the investigational drug formulation.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diabetes, or psychiatric illness/social situations that would limit compliance with study requirements.
Received > 20 Gy prior radiation to large areas of the bone marrow Cancer
Phase I Clinic, Clinics and Surgery Center (CSC)
Vagus Nerve Stimulation Using the SetPoint System for Moderate to Severe Rheumatoid Arthritis: The RESET-RA Study (RESET-RA)
This is a research study to evaluate the safety and effectiveness of the SetPoint System (study device) for the treatment of patients with active, moderate-to- severe RA, who have had an inadequate response or intolerance to biologic or targeted synthetic Disease Modifying Anti-Rheumatic Drugs (DMARDs).
Michael Park
STUDY00018057
Inclusion Criteria:
• 22-75 years of age
• diagnosed with active moderate or severe Rheumatoid Arthritis (RA)
• poor response to usual treatments
Exclusion Criteria:
• untreated or poorly controlled psychiatric illness, including substance abuse
• regular use of tobacco products
• history of neurological or heart disease
• unable to have a MRI
Bone, Joint & Muscle
Rheumatoid Arthritis (RA)
ARST2032: A Prospective Phase 3 Study of Patients with Newly Diagnosed Very Low-risk and Low-risk Fusion Negative Rhabdomyosarcoma
Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body. This phase III trial aims to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized molecular risk stratification in the treatment of rhabdomyosarcoma. Another aim of the study it to find out how well patients with low risk rhabdomyosarcoma (LR-RMS) respond to standard chemotherapy when patients with VLR-RMS and patients who have rhabdomyosarcoma with DNA mutations get separate treatment. Finally, this study examines the effect of therapy intensification in patients who have RMS cancer with DNA mutations to see if their outcomes can be improved.
Emily Greengard
STUDY00018465
Inclusion Criteria:
• 21 or younger at time of enrollment
• newly diagnosed embryonal rhabdomyosarcoma (ERMS), spindle cell/sclerosing RMS, or FOXO1 fusion negative alveolar rhabdomyosarcoma
• must be enrolled in APEC14B1 (NCT02402244) prior to enrollment and treatment on ARST2032 (this trial)
• contact study team for more detailed criteria
Exclusion Criteria:
• received prior chemotherapy and/or radiation therapy for cancer prior to enrollment
• unable to undergo radiation therapy
• Females who are pregnant
Cancer, Cancer, Children's Health
Childhood Cancer, Rhabdomyosarcoma, Soft Tissue and Bone Cancer, Soft Tissue and Bone Cancer, Embryonal Rhabdomyosarcoma, Spindle Cell/Sclerosing Rhabdomyosarcoma
Effects of Pallidal Deep Brain Stimulation Location on Motor Impairment in Parkinsons disease; Udall Project 2 Aims 1 & 2 Study
This protocol will characterize the effects of deep brain stimulation (DBS) location (both adverse and beneficial) on motor signs in people with Parkinson’s disease (PD). This information can be used to inform future DBS protocols to tailor stimulation to the specific needs of a patient. If targeted dorsal GP stimulation is shown to significantly improve motor features that are typically resistant to dopamine replacement therapy, these experiments will likely have major impact on clinical practice by providing a potential strategy to these medically intractable symptoms.
Colum MacKinnon
1608M93561
Inclusion Criteria:
• diagnosis of idiopathic Parkinson's Disease (PD)
• have a deep brain stimulator (DBS)
• have had a 7T brain scan
Exclusion Criteria:
• history of musculoskeletal disorders that significantly affect movement of the upper or lower limbs
• other significant neurological disorder
• history of dementia or cognitive impairment
• post-operative complications or adverse effects of DBS
Brain & Nervous System
Clinics and Surgery Center (CSC), DBS, Deep Brain Stimulator, Parkinson's Disease, PD
Efficacy and safety of GLP-1 agonist therapy in overweight and obese subjects with cystic fibrosis-related diabetes: a pilot study
In this study we will be looking at the safety and effectiveness of the medication GLP-1 (Semaglutide) in patients who are overweight and have been diagnosed with Cystic Fibrosis Related Diabetes (CFRD).
Amir Moheet
STUDY00018575
Inclusion Criteria:
• diagnosis of cystic fibrosis
• diabetic using insulin
• BMI 26 kg/m2 or greater
• able to read & speak English
Exclusion Criteria:
• personal or family history of medullary thyroid cancer
• chronic GI problems requiring hospitalization in the past year
• history of suicide attempts or active ideas of suicide
Rare Diseases, Breathing, Lung & Sleep Health
Cystic Fibrosis, Clinics and Surgery Center (CSC)
An Early Feasibility Study Assessing Treatment of Pulmonary Arterial Hypertension Using the Aria CV Pulmonary Hypertension System (ASPIRE PH) (ASPIRE PH)
The objective of this Early Feasibility Study is to evaluate the safety and performance of the Aria CV PH System in patients with pulmonary arterial hypertension (PAH).
Thenappan Thenappan
STUDY00011174
Inclusion Criteria:
18 years or older.
Diagnosis of WHO Group 1 PH (Pulmonary Arterial Hypertension, PAH) evidenced by all the following parameters measured at rest:
Mean pulmonary artery pressure (mPAP) ≥25 mmHg;
Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) ≤15 mmHg;
Pulmonary vascular resistance (PVR) >3 Wood units.
Patient remains symptomatic despite being on a stable drug regimen of at least two PH specific medications for at least 90 days prior to planned index procedure.
Patient with a current assessment of WHO Functional Class (FC) III or ambulatory IV.
Main pulmonary artery (MPA) diameter and anatomy suitable for placement of the device as defined in the Instructions For Use (IFU) and as assessed by multi-slice computed tomography (MSCT).
Patient is deemed appropriate for Aria CV device by the Patient Care Team at the investigation site and approved by the Central Screening Committee (CSC).
Patient understands the study requirements, is willing and able to provide appropriate informed consent and is committed and able to attend all required follow-up visits and undergo all required tests at the clinic.
Exclusion Criteria:
Diagnosis of WHO PH Groups 2, 3, 4 or 5.
Patient with recent clinical events of any of the following:
Myocardial infarction or stroke within 6 months prior to the index procedure;
Sustained tachyarrhythmia (documented heart rate >110/min) within 2 months prior to the index procedure.
Any pre-existing or requirement of emergent surgery/ intervention, or implantation of prosthetic cardiac device that may interfere with Aria CV device placement or function (e.g. pulmonary or tricuspid valve repair or replacement, pacemaker, defibrillator, inferior vena cava filters, neurostimulators, drug infusion devices, etc.).
Patient with any of the following medical history or comorbidities:
History of endocarditis;
Current renal insufficiency as demonstrated by an eGFR <30 mL/min/1.73 m^2 or end stage renal disease requiring chronic dialysis;
Current diagnosis of scleroderma associated with:
i. Any history of GI bleeding or receiving iron infusions within 2 years prior to enrollment;
ii. Significant skin involvement that could compromise daily activities or the ability to receive IV medications, or sclerodactyly that causes surface ulcerations, digital ulcerations, or ulcerating calcinosis lesions.
d. History of receiving immunosuppressant therapy as follows:
i. Excluded if receiving Mycophenolate mofetil within 30 days prior to enrollment, or Rituximab within 6 months prior to enrollment, or currently receiving Prednisone at a dose > 12 mg per day at time of enrollment.
ii. Excluded if any immunosuppressant other than Mycophenolate mofetil, Rituximab, or Prednisone, per above.
e. Current pulmonary veno-occlusive disease (PVOD);
f. Current pulmonary capillary hemangiomatosis (PCH);
g. History of clinically significant patent foramen ovale or other inter-atrial or inter-ventricular shunt;
h. History of gastric antral vascular ectasia (GAVE), gastrointestinal or intracranial bleeding which, in the opinion of the investigator, will predispose subject to major bleeding events following Aria CV device placement and warfarin anticoagulation regimen;
i. Current active systemic infection requiring antibiotic therapy;
j. Blood dyscrasias that may, in the opinion of investigator(s), expose patient to unacceptable procedural risks such as severe or worsening leukopenia, anemia, thrombocytopenia, untreated iron deficiency or history of bleeding diathesis or coagulopathy.
Anatomy not suitable for placement of Aria CV device, including
No suitable subcutaneous implantation location for the reservoir;
Contraindication to 22 Fr venous access via a subclavian vein;
Body habitus that precludes safe placement of any components of the Aria CV device.
Right heart valve regurgitation:
Moderate to severe (Grade 3 or 4) pulmonary valve regurgitation;
Severe (Grade 4) tricuspid valve regurgitation.
Hypersensitivity or contraindication to
Required medications (e.g. contrast agents, warfarin, heparin) which cannot be adequately managed;
Materials in device including polyurethane, silicone, nickel, and titanium.
Patient ineligible for or refuses blood transfusion.
Pregnant or lactating female or planning a pregnancy during participation in the study.
Patient with life expectancy of less than two years.
Currently participating in or planning to participate in other investigational drug or device trials that may interfere with the outcome of this studyA Phase IB/II Multi-Cohort Study of Targeted Agents with Atezolizumab for Patients with Recurrent or Persistent Endometrial Cancer (EndoMAP)
The purpose of this study is to learn the effects, good or bad, of several possible study treatments for EndoCA that are selected based on genetic markers that can be found in these tumors.
Britt Erickson
STUDY00013241
Inclusion Criteria:
• recurrent or persistent endometrial carcinoma which has progressed or recurred after at least 1, but no more than 2, prior lines of therapy
Exclusion Criteria:
• primary invasive ovarian or cervical cancer occurring with this cancer
• other cancer occurring in the past 5 years
• active or history of autoimmune disease or immune deficiency
• history of cardiac, respiratory or neurological conditions (study staff will review)
Cancer, Women's Health
Clinics and Surgery Center (CSC), EndoCA, Endometrial Cancer
A Phase II Study of Pembrolizumab Monotherapy in Recurrent Ovarian Cancer of the Immunoreactive Subtype determined by NanoString Gene Expression Profiling
To evaluate clinical anti-tumor activity of pembrolizumab monotherapy based on ORR as assessed by the investigator per irRECIST in patients with ROC whose tumors show an immunoreactive gene expression signature
Boris Winterhoff
STUDY00006054
Inclusion Criteria:
Be willing and able to provide written informed consent/assent for the trial
Have received 1-5 prior lines for treating ROC (i.e. 2-6 total prior lines counting the front line) and must have a platinum-free interval (PFI) or a treatment-free interval (TFI) >= 3 months based on the last regimen received
Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Note: Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
Have histologically diagnosed recurrent epithelial ovarian, fallopian or primary peritoneal ovarian cancer
Have provided a tumor tissue sample either collected from a newly obtained tumor tissue biopsy or an archival tissue specimen. Subjects for whom newly obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived biopsy specimen. Formalin-fixed paraffin embedded (FFPE) block specimens are preferred to 20 unstained slides. Additional samples may be requested if tumor tissue provided is not adequate for quality and/or quantity as assessed by the central laboratory
Performed within 10 days of treatment initiation: absolute neutrophil count (ANC) >= 1,500/mcL
Performed within 10 days of treatment initiation: platelets >= 100,000/mcL
Performed within 10 days of treatment initiation: hemoglobin >= 9 g/dL or >= 5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment)
Performed within 10 days of treatment initiation: serum creatinine OR measured or calculated creatinine clearance (CrCl) (glomerular filtration rate [GFR] can also be used in place of creatinine or CrCl) =< 1.5 x upper limit of normal (ULN) OR >= 45 mL/min for subject with creatinine levels > 1.5 x institutional ULN
Creatinine clearance should be calculated per institutional standard
Performed within 10 days of treatment initiation: serum total bilirubin =<1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN
Performed within 10 days of treatment initiation: aspartate aminotransferase (AST) (serum glutamate pyruvate transaminase [SGOT]) and aspartate aminotransferase (ALT) (serum glutamic-oxaloacetic transaminase [SGPT]) =< 2.5 x ULN OR =< 5 x ULN for subjects with liver metastases
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Have received front line platinum-based chemotherapy (preoperative chemotherapy is allowed)
Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication
Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Exclusion Criteria:
Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 2 weeks of the first dose of treatment
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
Has a known history of active TB (Bacillus Tuberculosis)
Hypersensitivity to pembrolizumab or any of its excipients
Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier
Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to a previously administered agent
Note: Subjects with =< grade 2 neuropathy are an exception to this criterion and may qualify for the study
Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects 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
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., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
Has known history of, or any evidence of active, non-infectious pneumonitis
Has an active infection requiring systemic therapy
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject?s participation for the full duration of the trial, 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 trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
Has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)
Has received a live vaccine within 30 days of planned start of study therapy
Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed Clinics and Surgery Center (CSC)
I-SPY 2 TRIAL -Investigation of Serial Studies to Predict your Therapeutic Response with Imaging and Molecular Analysis 2 (I-SPY)
To determine whether adding experimental agents to standard neoadjuvant paclitaxel (with or without trastuzumab), doxorubicin, and cyclophosphamide increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy for each biomarker signature established at trial entry, and to determine for each experimental agent used, the predictive probability of success in a subsequent phase 3 trial for each possible biomarker signature.
Douglas Yee, MD
STUDY00011111
Inclusion Criteria:
Histologically confirmed invasive cancer of the breast
Clinically or radiologically measureable disease in the breast after diagnostic biopsy, defined as longest diameter greater than or equal to 25 mm (2.5cm)
No prior cytotoxic regimens are allowed for this malignancy. Patients may not have had prior chemotherapy or prior radiation therapy to the ipsilateral breast for this malignancy. Prior bis-phosphonate therapy is allowed
Age ≥18 years
ECOG performance status 0-1
Willing to undergo core biopsy of the primary breast lesion to assess baseline biomarkers
Non-pregnant and non-lactating
No ferromagnetic prostheses. Patients who have metallic surgical implants that are not compatible with an MRI machine are not eligible.
Ability to understand and willingness to sign a written informed consent (I-SPY TRIAL Screening Consent)
Eligible tumors must meet one of the following criteria: Stage II or III, or T4, any N, M0, including clinical or pathologic inflammatory cancer or Regional Stage IV, where supraclavicular lymph nodes are the only sites metastasis
Any tumor ER/PgR status, any HER-2/neu status as measured by local hospital pathology laboratory and meets any tumor assay profile described in protocol section 4.1.2F
Normal organ and marrow function: Leukocytes ≥ 3000/μL, Absolute neutrophil count ≥ 1500/μL, Platelets ≥ 100,000/μL, Total bilirubin within normal institutional limits, unless patient has Gilbert's disease, for which bilirubin must be ≤ 2.0 x ULN, AST(SGOT)/ALT (SGPT) ≤ 1.5 x institutional ULN, creatinine < 1.5 x institutional ULN
No uncontrolled or severe cardiac disease. Baseline ejection fraction (by nuclear imaging or echocardiography) must by ≥ 50%
No clinical or imaging evidence of distant metastases by PA and Lateral CXR, Radionuclide Bone scan, and LFTs including total bilirubin, ALT, AST, and alkaline phosphatase
Tumor assay profile must include on of the following: MammaPrint High, any ER status, any HER2 status, or MammaPrint Low, ER negative (<5%), any HER2 status, or MammaPrint Low, ER positive, HER2/neu positive by any one of the three methods used (IHC, FISH, TargetPrint™)
Ability to understand and willingness to sign a written informed consent document (I-SPY 2 TRIAL Consent #2)
Exclusion Criteria:
Use of any other investigational agents within 30 days of starting study treatment
History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agent or accompanying supportive medications.
Uncontrolled intercurrent 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 requirementsMT2022-56: A Phase I Study of FT576 as Monotherapy and in Combination with Daratumumab in Subjects with Relapsed/Refractory Multiple Myeloma
This is a phase 1 study intended to determine the maximum safe dose of FT576, an genetically modified cellular therapy product, for treating relapsed or refractory multiple myeloma, both as a single therapy and in combination with Daratumumab, a monoclonal antibody already FDA approved for the treatment of multiple myeloma. It will also evaluate the safety and tolerability of FT576 for this population.
Aimee Merino
STUDY00017877
Inclusion Criteria:
• diagnosis of multiple myeloma after 3 or more previous treatments
• able to complete activities of daily living with minimal help
Exclusion Criteria:
• history of significant heart disease
• low red or white blood counts
• abnormal liver function tests
Cancer
Blood Cancers, Multiple Myeloma, Myeloma, Clinics and Surgery Center (CSC)
ARACOG: A Randomized Phase II Study of Androgen Receptor Directed Therapy on COGnitive Function in Patients Treated with Darolutamide or Enzalutamide (ARACOG)
To compare the effects of treatment with enzalutamide (ENZ) versus darolutamide (DARO) on the cognitive function of men with non-metastatic and metastatic castration-resistant prostate cancer (mCRPC) by comparing the change in the maximally changed cognitive domain from baseline in patients in each study arm by 24 weeks.
Stuart Bloom
STUDY00010912
Inclusion Criteria:
• confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
• castration-resistant prostate cancer defined as 3 PSA rises at least 1 week apart, with the last PSA >2 ng/mL, while on treatment
• testosterone level of <50 ng/dL
• able to walk and care for self, but unable to work
• able to read & speak English
• able to swallow study tablets whole
Exclusion Criteria:
• prior chemotherapy for treatment of CRPC. Men who received chemotherapy for castrate-sensitive prostate cancer are eligible provided chemotherapy was completed more than 6 months ago
• prior treatment with specific drugs (study staff will review)
• radiation treatment for more than 21 days during enrollment in the study
• neurological diseases that affect thinking (dementia, seizures, etc.)
• chronic use of opiates that affects thinking
• significant history of falls or risk of falls
Cancer
Clinics and Surgery Center (CSC), Castration Resistant Prostate Cancer, CRPC, Metastatic Prostate Cancer, Prostate Cancer, Prostate Cancer