Kidney Cancer Clinical Trial
A Study of Combination Chemotherapy for Patients With Newly Diagnosed DAWT and Relapsed FHWT
Summary
This phase II trial studies how well combination chemotherapy works in treating patients with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) or favorable histology Wilms tumors (FHWT) that have come back (relapsed). Drugs used in chemotherapy regimens such as UH-3 (vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan) and ICE/Cyclo/Topo (ifosfamide, carboplatin, etoposide, cyclophosphamide, and topotecan) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help doctors find out what effects, good and/or bad, regimen UH-3 has on patients with newly diagnosed DAWT and standard risk relapsed FHWT (those treated with only 2 drugs for the initial WT) and regimen ICE/Cyclo/Topo has on patients with high and very high risk relapsed FHWT (those treated with 3 or more drugs for the initial WT).
Full Description
PRIMARY OBJECTIVES:
I. To evaluate whether the addition of vincristine/irinotecan to cyclophosphamide/ carboplatin/etoposide alternating with vincristine/doxorubicin/cyclophosphamide improves the event-free survival (EFS) of patients with newly diagnosed stage 4 diffuse anaplastic Wilms tumor (DAWT) as compared to historical controls.
II. To evaluate whether the addition of vincristine/irinotecan to cyclophosphamide/carboplatin/etoposide alternating with vincristine/doxorubicin/cyclophosphamide improves the EFS of patients with standard-risk relapsed favorable histology Wilms tumor (SRrFHWT) as compared to historical controls.
SECONDARY OBJECTIVES:
I. To evaluate whether the addition of vincristine/irinotecan to cyclophosphamide/carboplatin/etoposide alternating with vincristine/doxorubicin/cyclophosphamide improves the overall survival (OS) of patients with newly diagnosed stage 4 DAWT as compared to historical controls.
II. To evaluate whether the addition of vincristine/irinotecan to cyclophosphamide/carboplatin/etoposide alternating with vincristine/doxorubicin/cyclophosphamide improves the OS of patients with SRrFHWT as compared to historical controls.
III. To evaluate whether the addition of vincristine/irinotecan to cyclophosphamide/carboplatin/etoposide alternating with vincristine/doxorubicin/cyclophosphamide improves the EFS and OS of patients with newly diagnosed stage 2 and 3 DAWT as compared to historical controls.
IV. To establish EFS and OS for high-risk (HRrFHWT) and very high risk (VHRrFHWT) relapsed favorable histology Wilms tumor treated with ifosfamide/carboplatin/etoposide alternating with cyclophosphamide/ topotecan.
EXPLORATORY OBJECTIVES:
I. To describe renal toxicity of ifosfamide/carboplatin/etoposide in HRrFHWT and VHRrFHWT patients using conventional and novel biomarkers of renal toxicity (urine NGAL, cystatin C and Kim1) in the context of the chemotherapy regimens used on this study.
II. To collect and bank serial blood and urine samples in patients with newly diagnosed DAWT or relapsed FHWT and tumor tissue in patients with relapsed FHWT, for future analysis.
III. To assess the impact of p53 gene and protein expression on outcome for patients with newly diagnosed DAWT.
IV. To determine EFS/OS in the subsets of patients with newly diagnosed DAWT or relapsed FWHT who undergo gross total resection at all disease sites at diagnosis or after neoadjuvant chemotherapy.
V. To describe the rate of regional lymph node sampling at the time of nephrectomy with the use of a pre-operative surgical checklist for patients with newly diagnosed DAWT.
VI. To determine the feasibility of intensity modulated radiation therapy (IMRT) with central quality assurance (QA) monitoring to reduce radiation induced toxicity to the heart, thyroid, breast and solitary kidney for children with lung and liver metastases (part of an overarching aim in this study and across frontline favorable histology Wilms tumor studies).
OUTLINE: Patients are assigned to 1 of 2 arms.
ARM I (REGIMEN UH-3):
CYCLES 1, 5, 7, 10, AND 13: Patients receive vincristine intravenously (IV) via minibag per institutional policy on days 1, 8, and 15. Patients also receive doxorubicin IV over 1-15 minutes and cyclophosphamide IV over 30-60 minutes on day 1. Treatment repeats every 21 days during cycles 1, 5, 7, 10, and 13 in the absence of disease progression or unacceptable toxicity.
CYCLES 2, 6, 9, 12, AND 14: Patients receive carboplatin IV over 15-60 minutes on day 1. Patients also receive cyclophosphamide IV over 15-30 minutes and etoposide IV over 1-2 hours on days 1-4. Treatment repeats every 21 days during cycles 2, 6, 9, 12, and 14 in the absence of disease progression or unacceptable toxicity.
CYCLES 3, 4, 8, AND 11: Patients receive vincristine IV via minibag per institutional policy on days 1 and 8 and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 21 days during cycles 3, 4, 8, and 11 in the absence of disease progression or unacceptable toxicity.
Patients undergo radiation therapy (RT) at week 7 of cycle 3 as clinically indicated. Patients undergo a computed tomography (CT) scan, a positron emission tomography (PET) scan, a chest x-ray, magnetic resonance imaging (MRI), an abdominal ultrasound, and/or a bone scan throughout the trial. Patients may also undergo blood specimen collection and biopsy throughout the trial.
ARM II (REGIMEN IFOSFAMIDE, CARBOPLATIN, ETOPOSIDE [ICE]/CYCLOPHOSPHAMIDE [CYCLO]/TOPOTECAN [TOPO]):
CYCLES 1, 2, 4, 5, 7, AND 9: Patients receive carboplatin IV over 15-60 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and ifosfamide IV over 2-4 hours on days 1-3. Treatment repeats every 21 days during cycles 1, 2, 4, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity.
CYCLES 3, 6, 8, AND 10: Patients receive cyclophosphamide IV over 15-30 minutes and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days during cycles 3, 6, 8, and 10 in the absence of disease progression or unacceptable toxicity.
Patients undergo surgery and/or RT during cycles 4, 7, and 10 as clinically indicated. Patients undergo a CT scan, a PET scan, a chest x-ray, MRI, an abdominal ultrasound, and/or a bone scan throughout the trial. Patients may also undergo blood specimen collection and biopsy throughout the trial.
After completion of study treatment, patients are followed up every 3 months for years 1-2, every 6 months for years 3-4, and once at year 5.
Eligibility Criteria
Inclusion Criteria:
Patients with newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor must be enrolled on AREN03B2 and have received an initial risk assignment showing DAWT (if anaplasia first identified at diagnostic, pre-treatment nephrectomy or biopsy) or a delayed nephrectomy classification showing DAWT (if anaplasia first noted at delayed nephrectomy) prior to enrollment on AREN1921. Prior enrollment on AREN03B2 is not an eligibility requirement for patients with relapsed favorable histology Wilms tumor.
Patients must be =< 30 years old at study enrollment
Patients with the following diagnoses are eligible for this study:
Newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor as confirmed by central review
Favorable histology Wilms tumor at first relapse. Relapsed FHWT patients must have previously achieved remission for their initial FHWT diagnosis to be eligible for this study. The relapse risk groups are defined as follows, regardless of radiation therapy:
Standard-Risk relapse: Patients who received two chemotherapy agents for frontline therapy; primarily actinomycin D and vincristine
High-Risk relapse: Patients who received three chemotherapy agents for frontline therapy; primarily vincristine, actinomycin D and doxorubicin or vincristine, actinomycin D and irinotecan
Very High-Risk relapse: Patients who received four or more chemotherapy agents as part of initial therapy; primarily regimen M or its variations
Patients with newly diagnosed DAWT must have had histologic verification of the malignancy. For relapsed FHWT patients, biopsy to prove recurrence is encouraged, but not required
Note: For relapsed FHWT patients, an institutional pathology report confirming favorable histology Wilms tumor (from relapse, if available, or from original diagnosis) must be available for upload prior to initiation of protocol therapy
Patients with newly diagnosed Stages 2 - 4 diffuse anaplastic Wilms tumor must be enrolled on AREN1921 within 2 weeks of the tumor-directed surgery or biopsy procedure that first confirms a diagnosis of DAWT, whether at initial diagnostic procedure or delayed nephrectomy (such surgery/biopsy is day 0). For patients who received prior therapy for presumed favorable histology Wilms tumor, later confirmed to have diffuse anaplastic Wilms tumor at subsequent review of the initial biopsy
Patients with newly diagnosed DAWT who undergo upfront nephrectomy must have at least 1 lymph node sampled prior to study enrollment
Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
Patients must have a life expectancy of >= 8 weeks
Diffuse Anaplastic Wilms Tumor: Patients with diffuse anaplastic histology must have had no prior systemic therapy, except in the following situations:
Patients with diffuse anaplastic Wilms tumor who received no more than 12 weeks of pre nephrectomy chemotherapy for what was originally presumed to be favorable histology Wilms tumor, subsequently confirmed to be diffuse anaplastic Wilms tumor at delayed nephrectomy
Patients with diffuse anaplastic Wilms tumor who received no more than 6 weeks of chemotherapy following upfront biopsy, initiated within 14 days of biopsy, for presumed favorable histology Wilms tumor based on institutional review, but subsequently corrected to diffuse anaplastic Wilms tumor based on the AREN03B2 initial risk assignment results (if available per current version of AREN03B2)
Treatment consisting of vincristine/doxorubicin/cyclophosphamide initiated on an emergent basis and within allowed timing as described
Note: Patients who received prior therapy for presumed favorable histology Wilms tumor, later identified to have diffuse anaplastic Wilms tumor as per above, must begin study treatment starting at cycle 3 (week 7) of regimen UH 3. Patients who received emergency radiation to preserve organ function are eligible as noted. Patients who received radiation as part of standard of care for presumed newly diagnosed favorable histology Wilms tumor, along with chemotherapy as noted above, prior to identification of diffuse anaplasia, are also eligible
Relapsed Favorable Histology Wilms Tumor: Patients must not have received prior chemotherapy for their relapsed favorable histology Wilms tumor diagnosis. In addition, patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study
Radiation therapy (RT): >= 2 weeks (wks) must have elapsed for local palliative RT (small port); >= 6 months must have elapsed if prior craniospinal RT or if >= 50% radiation of pelvis; >= 6 wks must have elapsed if other substantial bone marrow (BM) radiation. Patients with relapsed favorable histology Wilms tumor who received emergency radiation to preserve organ function are eligible and do not need to washout with the above criteria
Patients may not be receiving any other investigational agents (within 4 weeks prior to study enrollment)
Peripheral absolute neutrophil count (ANC) >= 750/uL (performed within 7 days prior to enrollment)
Platelet count >= 75,000/uL (transfusion independent) (performed within 7 days prior to enrollment)
Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions) (performed within 7 days prior to enrollment)
Patients with high-risk or very high-risk relapsed FHWT who will be treated with regimen ICE/Cyclo/Topo, must have renal function assessed by creatinine clearance or radioisotope glomerular filtration rate (GFR) and meet the following requirement:
Creatinine clearance or radioisotope GFR >= 60 mL/min/1.73 m^2 (performed within 7 days prior to enrollment)
Patients diagnosed with stage 2-4 DAWT or standard risk relapsed FHWT, who will be treated with regimen UH 3, may either obtain a creatinine clearance, radioisotope GFR (meeting the above criteria of GFR >= 60 mL/min/1.73 m^2), or an adequate serum creatinine as per the following table:
Age: Maximum Serum Creatinine (mg/dL)
1 month to < 6 months: 0.4 (male and female)
6 months to < 1 year: 0.5 (male and female)
1 to < 2 years: 0.6 (male and female)
2 to < 6 years: 0.8 (male and female)
6 to < 10 years: 1 (male and female)
10 to < 13 years: 1.2 (male and female)
13 to < 16 years: 1.5 (male), 1.4 (female)
>= 16 years: 1.7 (male), 1.4 (female)
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age or direct bilirubin =< ULN for patients whose total bilirubin > 1.5 x ULN (performed within 7 days prior to enrollment)
Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x upper limit of normal (ULN) for age or =< 5 x ULN for patients with liver metastases (performed within 7 days prior to enrollment)
Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by radionuclide angiogram (obtained within 21 days prior to enrollment and start of protocol therapy)
Exclusion Criteria:
Patients with a history of bilateral Wilms tumor (synchronous or metachronous)
Patients with any uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, or symptomatic congestive heart failure (defined as grade 2 or higher heart failure per Common Terminology Criteria for Adverse Events [CTCAE] version 5.0)
Relapsed FHWT patients who did not receive frontline chemotherapy (e.g., very low risk FHWT initially observed without chemotherapy) or received only one chemotherapy agent for frontline therapy
For patients with high-risk or very high-risk relapsed FHWT:
Patients with renal tubular acidosis (RTA) as evidenced by serum bicarbonate < 16 mmol/L and serum phosphate =< 2 mg/dL (or < 0.8 mmol/L) without supplementation
For stages 2-4 DAWT and standard-risk relapsed FHWT patients:
Chronic inflammatory bowel disease and/or bowel obstruction
Concomitant use of St. John's wort, which cannot be stopped prior to the start of trial treatment
Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential
Lactating females who plan to breastfeed their infants
Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
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There are 189 Locations for this study
Birmingham Alabama, 35233, United States More Info
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Mobile Alabama, 36604, United States More Info
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Anchorage Alaska, 99508, United States More Info
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Mesa Arizona, 85202, United States More Info
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Tucson Arizona, 85719, United States More Info
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Little Rock Arkansas, 72202, United States More Info
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Downey California, 90242, United States More Info
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Loma Linda California, 92354, United States More Info
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Long Beach California, 90806, United States More Info
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Los Angeles California, 90027, United States More Info
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Los Angeles California, 90048, United States More Info
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Los Angeles California, 90095, United States More Info
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Madera California, 93636, United States More Info
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Oakland California, 94609, United States
Oakland California, 94611, United States More Info
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Orange California, 92868, United States More Info
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Palo Alto California, 94304, United States More Info
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Sacramento California, 95817, United States More Info
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San Diego California, 92123, United States More Info
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San Francisco California, 94158, United States More Info
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Aurora Colorado, 80045, United States More Info
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Denver Colorado, 80218, United States More Info
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Hartford Connecticut, 06106, United States More Info
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New Haven Connecticut, 06520, United States More Info
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Wilmington Delaware, 19803, United States More Info
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Washington District of Columbia, 20007, United States More Info
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Washington District of Columbia, 20010, United States More Info
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Fort Myers Florida, 33908, United States More Info
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Gainesville Florida, 32610, United States More Info
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Hollywood Florida, 33021, United States More Info
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Jacksonville Florida, 32207, United States More Info
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Miami Florida, 33136, United States
Miami Florida, 33155, United States More Info
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Orlando Florida, 32806, United States More Info
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Orlando Florida, 32827, United States More Info
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Pensacola Florida, 32504, United States More Info
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Saint Petersburg Florida, 33701, United States More Info
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Tampa Florida, 33606, United States More Info
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Tampa Florida, 33607, United States More Info
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West Palm Beach Florida, 33407, United States More Info
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Atlanta Georgia, 30322, United States More Info
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Macon Georgia, 31201, United States More Info
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Savannah Georgia, 31404, United States More Info
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Honolulu Hawaii, 96826, United States More Info
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Boise Idaho, 83712, United States More Info
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Chicago Illinois, 60611, United States More Info
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Chicago Illinois, 60612, United States More Info
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Chicago Illinois, 60637, United States More Info
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Maywood Illinois, 60153, United States More Info
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Oak Lawn Illinois, 60453, United States More Info
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Park Ridge Illinois, 60068, United States More Info
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Peoria Illinois, 61637, United States More Info
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Springfield Illinois, 62702, United States More Info
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Indianapolis Indiana, 46202, United States More Info
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Des Moines Iowa, 50309, United States More Info
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Iowa City Iowa, 52242, United States More Info
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Lexington Kentucky, 40536, United States More Info
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Louisville Kentucky, 40202, United States More Info
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New Orleans Louisiana, 70118, United States More Info
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New Orleans Louisiana, 70121, United States More Info
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Bangor Maine, 04401, United States More Info
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Scarborough Maine, 04074, United States More Info
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Baltimore Maryland, 21215, United States More Info
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Baltimore Maryland, 21287, United States More Info
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Boston Massachusetts, 02111, United States
Boston Massachusetts, 02215, United States More Info
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Worcester Massachusetts, 01655, United States More Info
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Ann Arbor Michigan, 48109, United States More Info
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Detroit Michigan, 48201, United States More Info
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East Lansing Michigan, 48824, United States More Info
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Grand Rapids Michigan, 49503, United States More Info
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Kalamazoo Michigan, 49007, United States More Info
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Royal Oak Michigan, 48073, United States More Info
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Minneapolis Minnesota, 55404, United States More Info
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Minneapolis Minnesota, 55455, United States More Info
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Rochester Minnesota, 55905, United States More Info
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Jackson Mississippi, 39216, United States More Info
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Columbia Missouri, 65201, United States More Info
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Kansas City Missouri, 64108, United States More Info
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Saint Louis Missouri, 63104, United States More Info
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Saint Louis Missouri, 63110, United States More Info
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Saint Louis Missouri, 63141, United States More Info
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Omaha Nebraska, 68114, United States More Info
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Omaha Nebraska, 68198, United States More Info
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Las Vegas Nevada, 89102, United States More Info
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Las Vegas Nevada, 89109, United States More Info
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Las Vegas Nevada, 89135, United States More Info
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Las Vegas Nevada, 89144, United States More Info
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Reno Nevada, 89502, United States More Info
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Hackensack New Jersey, 07601, United States More Info
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Morristown New Jersey, 07960, United States More Info
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New Brunswick New Jersey, 08903, United States More Info
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Paterson New Jersey, 07503, United States More Info
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Albany New York, 12208, United States More Info
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Bronx New York, 10467, United States More Info
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Buffalo New York, 14263, United States More Info
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New Hyde Park New York, 11040, United States More Info
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New York New York, 10032, United States More Info
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New York New York, 10065, United States More Info
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New York New York, 10065, United States More Info
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Stony Brook New York, 11794, United States More Info
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Syracuse New York, 13210, United States More Info
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Valhalla New York, 10595, United States More Info
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Asheville North Carolina, 28801, United States More Info
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Charlotte North Carolina, 28203, United States More Info
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Charlotte North Carolina, 28204, United States More Info
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Durham North Carolina, 27710, United States More Info
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Greenville North Carolina, 27834, United States More Info
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Winston-Salem North Carolina, 27157, United States More Info
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Fargo North Dakota, 58122, United States More Info
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Akron Ohio, 44308, United States More Info
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Cincinnati Ohio, 45229, United States More Info
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Cleveland Ohio, 44106, United States More Info
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Cleveland Ohio, 44195, United States More Info
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Columbus Ohio, 43205, United States More Info
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Dayton Ohio, 45404, United States More Info
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Toledo Ohio, 43606, United States More Info
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Oklahoma City Oklahoma, 73104, United States More Info
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Portland Oregon, 97227, United States More Info
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Portland Oregon, 97239, United States More Info
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Allentown Pennsylvania, 18103, United States More Info
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Danville Pennsylvania, 17822, United States More Info
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Hershey Pennsylvania, 17033, United States More Info
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Philadelphia Pennsylvania, 19104, United States More Info
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Philadelphia Pennsylvania, 19134, United States More Info
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Pittsburgh Pennsylvania, 15224, United States More Info
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Providence Rhode Island, 02903, United States More Info
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Charleston South Carolina, 29425, United States More Info
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Columbia South Carolina, 29203, United States More Info
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Greenville South Carolina, 29605, United States More Info
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Sioux Falls South Dakota, 57117, United States More Info
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Chattanooga Tennessee, 37403, United States
Knoxville Tennessee, 37916, United States More Info
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Memphis Tennessee, 38105, United States More Info
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Nashville Tennessee, 37203, United States More Info
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Nashville Tennessee, 37232, United States More Info
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Amarillo Texas, 79106, United States More Info
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Austin Texas, 78723, United States More Info
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Corpus Christi Texas, 78411, United States More Info
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Dallas Texas, 75230, United States More Info
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Dallas Texas, 75390, United States More Info
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El Paso Texas, 79905, United States More Info
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Fort Worth Texas, 76104, United States More Info
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Houston Texas, 77030, United States More Info
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Houston Texas, 77030, United States
Lubbock Texas, 79410, United States More Info
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Lubbock Texas, 79415, United States More Info
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San Antonio Texas, 78207, United States More Info
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San Antonio Texas, 78229, United States More Info
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San Antonio Texas, 78229, United States More Info
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Salt Lake City Utah, 84113, United States More Info
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Charlottesville Virginia, 22908, United States More Info
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Falls Church Virginia, 22042, United States More Info
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Norfolk Virginia, 23507, United States More Info
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Richmond Virginia, 23298, United States More Info
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Roanoke Virginia, 24014, United States More Info
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Seattle Washington, 98105, United States More Info
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Spokane Washington, 99204, United States More Info
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Tacoma Washington, 98405, United States More Info
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Tacoma Washington, 98431, United States More Info
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Charleston West Virginia, 25304, United States More Info
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Huntington West Virginia, 25701, United States More Info
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Madison Wisconsin, 53792, United States More Info
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Marshfield Wisconsin, 54449, United States More Info
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Milwaukee Wisconsin, 53226, United States More Info
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Hunter Regional Mail Centre New South Wales, 2310, Australia More Info
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Randwick New South Wales, 2031, Australia More Info
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Westmead New South Wales, 2145, Australia More Info
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South Brisbane Queensland, 4101, Australia More Info
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North Adelaide South Australia, 5006, Australia More Info
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Clayton Victoria, 3168, Australia
Parkville Victoria, 3052, Australia More Info
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Perth Western Australia, 6009, Australia More Info
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Calgary Alberta, T3B 6, Canada More Info
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Edmonton Alberta, T6G 2, Canada More Info
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Vancouver British Columbia, V6H 3, Canada More Info
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Saint John's Newfoundland and Labrador, A1B 3, Canada More Info
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Hamilton Ontario, L8N 3, Canada More Info
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Ottawa Ontario, K1H 8, Canada More Info
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Toronto Ontario, M5G 1, Canada More Info
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Montreal Quebec, H3H 1, Canada More Info
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Montreal Quebec, H3T 1, Canada More Info
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Sherbrooke Quebec, J1H 5, Canada More Info
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Quebec , G1V 4, Canada More Info
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Grafton Auckland, 1145, New Zealand More Info
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Christchurch , 8011, New Zealand More Info
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Caguas , 00726, Puerto Rico
San Juan , 00926, Puerto Rico More Info
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Riyadh , 11211, Saudi Arabia More Info
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