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).

View Full Description

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.

View Eligibility Criteria

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

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Estimated Enrollment:

221

Study ID:

NCT04322318

Recruitment Status:

Recruiting

Sponsor:

Children's Oncology Group

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There are 189 Locations for this study

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Children's Hospital of Alabama
Birmingham Alabama, 35233, United States More Info
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205-638-9285
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Elizabeth D. Alva
Principal Investigator
USA Health Strada Patient Care Center
Mobile Alabama, 36604, United States More Info
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800-388-8721
Hamayun Imran
Principal Investigator
Providence Alaska Medical Center
Anchorage Alaska, 99508, United States More Info
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907-212-6871
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Brenda J. Wittman
Principal Investigator
Banner Children's at Desert
Mesa Arizona, 85202, United States More Info
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480-412-3100
Joseph C. Torkildson
Principal Investigator
Banner University Medical Center - Tucson
Tucson Arizona, 85719, United States More Info
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[email protected]
Michelina de la Maza
Principal Investigator
Arkansas Children's Hospital
Little Rock Arkansas, 72202, United States More Info
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501-364-7373
David L. Becton
Principal Investigator
Kaiser Permanente Downey Medical Center
Downey California, 90242, United States More Info
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626-564-3455
Neha G. Vaghasia
Principal Investigator
Loma Linda University Medical Center
Loma Linda California, 92354, United States More Info
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909-558-4050
Albert Kheradpour
Principal Investigator
Miller Children's and Women's Hospital Long Beach
Long Beach California, 90806, United States More Info
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562-933-5600
Jacqueline N. Casillas
Principal Investigator
Children's Hospital Los Angeles
Los Angeles California, 90027, United States More Info
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323-361-4110
Rachana Shah
Principal Investigator
Cedars Sinai Medical Center
Los Angeles California, 90048, United States More Info
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310-423-8965
Leo Mascarenhas
Principal Investigator
Mattel Children's Hospital UCLA
Los Angeles California, 90095, United States More Info
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310-825-6708
Noah C. Federman
Principal Investigator
Valley Children's Hospital
Madera California, 93636, United States More Info
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559-353-3000
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Karen S. Fernandez
Principal Investigator
UCSF Benioff Children's Hospital Oakland
Oakland California, 94609, United States
Kaiser Permanente-Oakland
Oakland California, 94611, United States More Info
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877-642-4691
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Aarati V. Rao
Principal Investigator
Children's Hospital of Orange County
Orange California, 92868, United States More Info
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714-509-8646
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Elyssa M. Rubin
Principal Investigator
Lucile Packard Children's Hospital Stanford University
Palo Alto California, 94304, United States More Info
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800-694-0012
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Jay Michael S. Balagtas
Principal Investigator
University of California Davis Comprehensive Cancer Center
Sacramento California, 95817, United States More Info
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916-734-3089
Marcio H. Malogolowkin
Principal Investigator
Rady Children's Hospital - San Diego
San Diego California, 92123, United States More Info
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858-966-5934
William D. Roberts
Principal Investigator
UCSF Medical Center-Mission Bay
San Francisco California, 94158, United States More Info
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877-827-3222
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Arun A. Rangaswami
Principal Investigator
Children's Hospital Colorado
Aurora Colorado, 80045, United States More Info
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303-764-5056
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Timothy P. Garrington
Principal Investigator
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver Colorado, 80218, United States More Info
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303-839-6000
Jennifer J. Clark
Principal Investigator
Connecticut Children's Medical Center
Hartford Connecticut, 06106, United States More Info
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860-545-9981
Michael S. Isakoff
Principal Investigator
Yale University
New Haven Connecticut, 06520, United States More Info
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203-785-5702
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Farzana Pashankar
Principal Investigator
Alfred I duPont Hospital for Children
Wilmington Delaware, 19803, United States More Info
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302-651-5572
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Ramamoorthy Nagasubramanian
Principal Investigator
MedStar Georgetown University Hospital
Washington District of Columbia, 20007, United States More Info
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202-444-2223
Caileigh Pudela
Principal Investigator
Children's National Medical Center
Washington District of Columbia, 20010, United States More Info
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202-476-2800
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Jeffrey S. Dome
Principal Investigator
Golisano Children's Hospital of Southwest Florida
Fort Myers Florida, 33908, United States More Info
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239-343-5333
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Emad K. Salman
Principal Investigator
University of Florida Health Science Center - Gainesville
Gainesville Florida, 32610, United States More Info
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352-273-8010
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William B. Slayton
Principal Investigator
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood Florida, 33021, United States More Info
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954-265-1847
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Iftikhar Hanif
Principal Investigator
Nemours Children's Clinic-Jacksonville
Jacksonville Florida, 32207, United States More Info
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302-651-5572
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Ramamoorthy Nagasubramanian
Principal Investigator
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami Florida, 33136, United States
Nicklaus Children's Hospital
Miami Florida, 33155, United States More Info
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888-624-2778
Maggie E. Fader
Principal Investigator
Arnold Palmer Hospital for Children
Orlando Florida, 32806, United States More Info
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321-841-5357
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Amy A. Smith
Principal Investigator
Nemours Children's Hospital
Orlando Florida, 32827, United States More Info
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302-651-5572
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Ramamoorthy Nagasubramanian
Principal Investigator
Sacred Heart Hospital
Pensacola Florida, 32504, United States More Info
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850-416-4611
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Erlyn C. Smith
Principal Investigator
Johns Hopkins All Children's Hospital
Saint Petersburg Florida, 33701, United States More Info
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727-767-4784
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Jonathan L. Metts
Principal Investigator
Tampa General Hospital
Tampa Florida, 33606, United States More Info
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813-844-7829
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Andrew J. Galligan
Principal Investigator
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa Florida, 33607, United States More Info
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813-357-0849
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Don E. Eslin
Principal Investigator
Saint Mary's Hospital
West Palm Beach Florida, 33407, United States More Info
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561-881-2815
Muaz A. Alrazzak
Principal Investigator
Children's Healthcare of Atlanta - Egleston
Atlanta Georgia, 30322, United States More Info
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404-785-2025
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Andrew L. Hong
Principal Investigator
Medical Center of Central Georgia
Macon Georgia, 31201, United States More Info
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478-633-2152
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Sushmita Nair
Principal Investigator
Memorial Health University Medical Center
Savannah Georgia, 31404, United States More Info
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912-350-7887
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Andrew L. Pendleton
Principal Investigator
Kapiolani Medical Center for Women and Children
Honolulu Hawaii, 96826, United States More Info
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808-983-6090
Wade T. Kyono
Principal Investigator
Saint Luke's Cancer Institute - Boise
Boise Idaho, 83712, United States More Info
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208-381-2774
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Martha M. Pacheco
Principal Investigator
Lurie Children's Hospital-Chicago
Chicago Illinois, 60611, United States More Info
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773-880-4562
Amy L. Walz
Principal Investigator
University of Illinois
Chicago Illinois, 60612, United States More Info
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312-355-3046
Mary L. Schmidt
Principal Investigator
University of Chicago Comprehensive Cancer Center
Chicago Illinois, 60637, United States More Info
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773-702-8222
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Ami V. Desai
Principal Investigator
Loyola University Medical Center
Maywood Illinois, 60153, United States More Info
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708-226-4357
Eugene Suh
Principal Investigator
Advocate Children's Hospital-Oak Lawn
Oak Lawn Illinois, 60453, United States More Info
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847-723-7570
Rebecca E. McFall
Principal Investigator
Advocate Children's Hospital-Park Ridge
Park Ridge Illinois, 60068, United States More Info
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[email protected]
Rebecca E. McFall
Principal Investigator
Saint Jude Midwest Affiliate
Peoria Illinois, 61637, United States More Info
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888-226-4343
Prerna Kumar
Principal Investigator
Southern Illinois University School of Medicine
Springfield Illinois, 62702, United States More Info
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217-545-7929
Gregory P. Brandt
Principal Investigator
Riley Hospital for Children
Indianapolis Indiana, 46202, United States More Info
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800-248-1199
Melissa K. Bear
Principal Investigator
Blank Children's Hospital
Des Moines Iowa, 50309, United States More Info
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515-241-8912
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Samantha L. Mallory
Principal Investigator
University of Iowa/Holden Comprehensive Cancer Center
Iowa City Iowa, 52242, United States More Info
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800-237-1225
David S. Dickens
Principal Investigator
University of Kentucky/Markey Cancer Center
Lexington Kentucky, 40536, United States More Info
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859-257-3379
James T. Badgett
Principal Investigator
Norton Children's Hospital
Louisville Kentucky, 40202, United States More Info
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502-629-5500
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Ashok B. Raj
Principal Investigator
Children's Hospital New Orleans
New Orleans Louisiana, 70118, United States More Info
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[email protected]
Lolie C. Yu
Principal Investigator
Ochsner Medical Center Jefferson
New Orleans Louisiana, 70121, United States More Info
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504-842-8084
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Craig Lotterman
Principal Investigator
Eastern Maine Medical Center
Bangor Maine, 04401, United States More Info
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207-973-4274
Daniel L. Callaway
Principal Investigator
Maine Children's Cancer Program
Scarborough Maine, 04074, United States More Info
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207-396-7581
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Aaron R. Weiss
Principal Investigator
Sinai Hospital of Baltimore
Baltimore Maryland, 21215, United States More Info
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410-601-6120
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Jason M. Fixler
Principal Investigator
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore Maryland, 21287, United States More Info
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410-955-8804
[email protected]
Alan D. Friedman
Principal Investigator
Tufts Children's Hospital
Boston Massachusetts, 02111, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
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877-442-3324
Elizabeth A. Mullen
Principal Investigator
UMass Memorial Medical Center - University Campus
Worcester Massachusetts, 01655, United States More Info
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508-856-3216
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Stefanie R. Lowas
Principal Investigator
C S Mott Children's Hospital
Ann Arbor Michigan, 48109, United States More Info
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800-865-1125
Rama Jasty
Principal Investigator
Children's Hospital of Michigan
Detroit Michigan, 48201, United States More Info
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[email protected]
Alissa M. Martin
Principal Investigator
Michigan State University Clinical Center
East Lansing Michigan, 48824, United States More Info
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517-975-9547
Laura E. Agresta
Principal Investigator
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids Michigan, 49503, United States More Info
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616-267-1925
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Kathleen J. Yost
Principal Investigator
Bronson Methodist Hospital
Kalamazoo Michigan, 49007, United States More Info
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616-391-1230
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Kathleen J. Yost
Principal Investigator
Beaumont Children's Hospital-Royal Oak
Royal Oak Michigan, 48073, United States More Info
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248-551-7695
Laura K. Gowans
Principal Investigator
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis Minnesota, 55404, United States More Info
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612-813-5913
[email protected]
Michael K. Richards
Principal Investigator
University of Minnesota/Masonic Cancer Center
Minneapolis Minnesota, 55455, United States More Info
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612-624-2620
Emily G. Greengard
Principal Investigator
Mayo Clinic in Rochester
Rochester Minnesota, 55905, United States More Info
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855-776-0015
Wendy Allen-Rhoades
Principal Investigator
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States More Info
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601-815-6700
Betty L. Herrington
Principal Investigator
Columbia Regional
Columbia Missouri, 65201, United States More Info
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[email protected]
Barbara A. Gruner
Principal Investigator
Children's Mercy Hospitals and Clinics
Kansas City Missouri, 64108, United States More Info
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816-302-6808
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Keith J. August
Principal Investigator
Cardinal Glennon Children's Medical Center
Saint Louis Missouri, 63104, United States More Info
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314-268-4000
William S. Ferguson
Principal Investigator
Washington University School of Medicine
Saint Louis Missouri, 63110, United States More Info
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800-600-3606
[email protected]
Amy Armstrong
Principal Investigator
Mercy Hospital Saint Louis
Saint Louis Missouri, 63141, United States More Info
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314-251-7066
Robin D. Hanson
Principal Investigator
Children's Hospital and Medical Center of Omaha
Omaha Nebraska, 68114, United States More Info
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402-955-3949
Jill C. Beck
Principal Investigator
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States More Info
Site Public Contact
Contact
402-559-6941
[email protected]
Jill C. Beck
Principal Investigator
University Medical Center of Southern Nevada
Las Vegas Nevada, 89102, United States More Info
Site Public Contact
Contact
702-384-0013
[email protected]
Alan K. Ikeda
Principal Investigator
Sunrise Hospital and Medical Center
Las Vegas Nevada, 89109, United States More Info
Site Public Contact
Contact
702-384-0013
[email protected]
Alan K. Ikeda
Principal Investigator
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas Nevada, 89135, United States More Info
Site Public Contact
Contact
702-384-0013
[email protected]
Alan K. Ikeda
Principal Investigator
Summerlin Hospital Medical Center
Las Vegas Nevada, 89144, United States More Info
Site Public Contact
Contact
702-384-0013
[email protected]
Alan K. Ikeda
Principal Investigator
Renown Regional Medical Center
Reno Nevada, 89502, United States More Info
Site Public Contact
Contact
702-384-0013
[email protected]
Alan K. Ikeda
Principal Investigator
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States More Info
Site Public Contact
Contact
201-996-2879
Katharine Offer
Principal Investigator
Morristown Medical Center
Morristown New Jersey, 07960, United States More Info
Site Public Contact
Contact
973-971-5900
Kathryn L. Laurie
Principal Investigator
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick New Jersey, 08903, United States More Info
Site Public Contact
Contact
732-235-8675
Scott Moerdler
Principal Investigator
Saint Joseph's Regional Medical Center
Paterson New Jersey, 07503, United States More Info
Site Public Contact
Contact
973-754-2207
[email protected]
Alissa Kahn
Principal Investigator
Albany Medical Center
Albany New York, 12208, United States More Info
Site Public Contact
Contact
518-262-5513
Lauren R. Weintraub
Principal Investigator
Montefiore Medical Center - Moses Campus
Bronx New York, 10467, United States More Info
Site Public Contact
Contact
718-379-6866
[email protected]
Alice Lee
Principal Investigator
Roswell Park Cancer Institute
Buffalo New York, 14263, United States More Info
Site Public Contact
Contact
800-767-9355
[email protected]
Clare J. Twist
Principal Investigator
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park New York, 11040, United States More Info
Site Public Contact
Contact
718-470-3460
Carolyn F. Levy
Principal Investigator
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York New York, 10032, United States More Info
Site Public Contact
Contact
212-305-6361
[email protected]
Nobuko Hijiya
Principal Investigator
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Site Public Contact
Contact
212-639-7592
Michael V. Ortiz
Principal Investigator
NYP/Weill Cornell Medical Center
New York New York, 10065, United States More Info
Site Public Contact
Contact
212-746-1848
Lisa G. Roth
Principal Investigator
Stony Brook University Medical Center
Stony Brook New York, 11794, United States More Info
Site Public Contact
Contact
800-862-2215
Laura E. Hogan
Principal Investigator
State University of New York Upstate Medical University
Syracuse New York, 13210, United States More Info
Site Public Contact
Contact
315-464-5476
Philip M. Monteleone
Principal Investigator
New York Medical College
Valhalla New York, 10595, United States More Info
Site Public Contact
Contact
914-594-3794
Jessica C. Hochberg
Principal Investigator
Mission Hospital
Asheville North Carolina, 28801, United States More Info
Site Public Contact
Contact
828-213-7055
[email protected]
Douglas J. Scothorn
Principal Investigator
Carolinas Medical Center/Levine Cancer Institute
Charlotte North Carolina, 28203, United States More Info
Site Public Contact
Contact
800-804-9376
Joel A. Kaplan
Principal Investigator
Novant Health Presbyterian Medical Center
Charlotte North Carolina, 28204, United States More Info
Site Public Contact
Contact
980-201-6360
[email protected]
Jessica A. Bell
Principal Investigator
Duke University Medical Center
Durham North Carolina, 27710, United States More Info
Site Public Contact
Contact
888-275-3853
Jessica M. Sun
Principal Investigator
East Carolina University
Greenville North Carolina, 27834, United States More Info
Site Public Contact
Contact
252-744-1015
[email protected]
Andrea R. Whitfield
Principal Investigator
Wake Forest University Health Sciences
Winston-Salem North Carolina, 27157, United States More Info
Site Public Contact
Contact
336-713-6771
Thomas W. McLean
Principal Investigator
Sanford Broadway Medical Center
Fargo North Dakota, 58122, United States More Info
Site Public Contact
Contact
701-323-5760
[email protected]
Samuel J. Milanovich
Principal Investigator
Children's Hospital Medical Center of Akron
Akron Ohio, 44308, United States More Info
Site Public Contact
Contact
330-543-3193
Erin Wright
Principal Investigator
Cincinnati Children's Hospital Medical Center
Cincinnati Ohio, 45229, United States More Info
Site Public Contact
Contact
513-636-2799
[email protected]
James I. Geller
Principal Investigator
Rainbow Babies and Childrens Hospital
Cleveland Ohio, 44106, United States More Info
Site Public Contact
Contact
216-844-5437
Duncan S. Stearns
Principal Investigator
Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States More Info
Site Public Contact
Contact
866-223-8100
[email protected]
Rabi Hanna
Principal Investigator
Nationwide Children's Hospital
Columbus Ohio, 43205, United States More Info
Site Public Contact
Contact
614-722-6039
[email protected]
Mark A. Ranalli
Principal Investigator
Dayton Children's Hospital
Dayton Ohio, 45404, United States More Info
Site Public Contact
Contact
800-228-4055
Mukund G. Dole
Principal Investigator
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo Ohio, 43606, United States More Info
Site Public Contact
Contact
419-824-1842
[email protected]
Jamie L. Dargart
Principal Investigator
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States More Info
Site Public Contact
Contact
405-271-8777
[email protected]
Rene Y. McNall-Knapp
Principal Investigator
Legacy Emanuel Children's Hospital
Portland Oregon, 97227, United States More Info
Site Public Contact
Contact
503-413-2560
Janice F. Olson
Principal Investigator
Oregon Health and Science University
Portland Oregon, 97239, United States More Info
Site Public Contact
Contact
503-494-1080
[email protected]
Katrina Winsnes
Principal Investigator
Lehigh Valley Hospital-Cedar Crest
Allentown Pennsylvania, 18103, United States More Info
Site Public Contact
Contact
610-402-9543
[email protected]
Jacob A. Troutman
Principal Investigator
Geisinger Medical Center
Danville Pennsylvania, 17822, United States More Info
Site Public Contact
Contact
570-271-5251
[email protected]
Jagadeesh Ramdas
Principal Investigator
Penn State Children's Hospital
Hershey Pennsylvania, 17033, United States More Info
Site Public Contact
Contact
717-531-6012
Lisa M. McGregor
Principal Investigator
Children's Hospital of Philadelphia
Philadelphia Pennsylvania, 19104, United States More Info
Site Public Contact
Contact
267-425-5544
[email protected]
Frank M. Balis
Principal Investigator
Saint Christopher's Hospital for Children
Philadelphia Pennsylvania, 19134, United States More Info
Site Public Contact
Contact
215-427-8991
Gregory E. Halligan
Principal Investigator
Children's Hospital of Pittsburgh of UPMC
Pittsburgh Pennsylvania, 15224, United States More Info
Site Public Contact
Contact
412-692-8570
[email protected]
Jean M. Tersak
Principal Investigator
Rhode Island Hospital
Providence Rhode Island, 02903, United States More Info
Site Public Contact
Contact
401-444-1488
Jennifer J. Welch
Principal Investigator
Medical University of South Carolina
Charleston South Carolina, 29425, United States More Info
Site Public Contact
Contact
843-792-9321
[email protected]
Jacqueline M. Kraveka
Principal Investigator
Prisma Health Richland Hospital
Columbia South Carolina, 29203, United States More Info
Site Public Contact
Contact
864-241-6251
Stuart L. Cramer
Principal Investigator
BI-LO Charities Children's Cancer Center
Greenville South Carolina, 29605, United States More Info
Site Public Contact
Contact
864-241-6251
Aniket Saha
Principal Investigator
Sanford USD Medical Center - Sioux Falls
Sioux Falls South Dakota, 57117, United States More Info
Site Public Contact
Contact
605-312-3320
[email protected]
Kayelyn J. Wagner
Principal Investigator
T C Thompson Children's Hospital
Chattanooga Tennessee, 37403, United States More Info
Site Public Contact
Contact
423-778-7289
Benjamin A. Mixon
Principal Investigator
East Tennessee Childrens Hospital
Knoxville Tennessee, 37916, United States More Info
Site Public Contact
Contact
865-541-8266
Susan E. Spiller
Principal Investigator
Saint Jude Children's Research Hospital
Memphis Tennessee, 38105, United States More Info
Site Public Contact
Contact
888-226-4343
[email protected]
Dylan Graetz
Principal Investigator
The Children's Hospital at TriStar Centennial
Nashville Tennessee, 37203, United States More Info
Site Public Contact
Contact
615-342-1919
Jennifer A. Domm
Principal Investigator
Vanderbilt University/Ingram Cancer Center
Nashville Tennessee, 37232, United States More Info
Site Public Contact
Contact
800-811-8480
Daniel J. Benedetti
Principal Investigator
Texas Tech University Health Sciences Center-Amarillo
Amarillo Texas, 79106, United States More Info
Site Public Contact
Contact
806-354-5411
Smita Bhaskaran
Principal Investigator
Dell Children's Medical Center of Central Texas
Austin Texas, 78723, United States More Info
Site Public Contact
Contact
512-628-1902
[email protected]
Shannon M. Cohn
Principal Investigator
Driscoll Children's Hospital
Corpus Christi Texas, 78411, United States More Info
Site Public Contact
Contact
361-694-5311
[email protected]
Nkechi I. Mba
Principal Investigator
Medical City Dallas Hospital
Dallas Texas, 75230, United States More Info
Site Public Contact
Contact
972-566-5588
Stanton C. Goldman
Principal Investigator
UT Southwestern/Simmons Cancer Center-Dallas
Dallas Texas, 75390, United States More Info
Site Public Contact
Contact
214-648-7097
[email protected]
Jonathan E. Wickiser
Principal Investigator
El Paso Children's Hospital
El Paso Texas, 79905, United States More Info
Site Public Contact
Contact
915-298-5444
[email protected]
Benjamin Carcamo
Principal Investigator
Cook Children's Medical Center
Fort Worth Texas, 76104, United States More Info
Site Public Contact
Contact
682-885-2103
[email protected]
Kelly L. Vallance
Principal Investigator
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston Texas, 77030, United States More Info
Site Public Contact
Contact
713-798-1354
[email protected]
Sarah B. Whittle
Principal Investigator
M D Anderson Cancer Center
Houston Texas, 77030, United States More Info
Site Public Contact
Contact
877-632-6789
[email protected]
Najat C. Daw
Principal Investigator
Covenant Children's Hospital
Lubbock Texas, 79410, United States More Info
Site Public Contact
Contact
806-725-8657
[email protected]
Kishor M. Bhende
Principal Investigator
UMC Cancer Center / UMC Health System
Lubbock Texas, 79415, United States More Info
Site Public Contact
Contact
806-775-8590
Erin K. Barr
Principal Investigator
Children's Hospital of San Antonio
San Antonio Texas, 78207, United States More Info
Site Public Contact
Contact
210-704-2894
[email protected]
Timothy C. Griffin
Principal Investigator
Methodist Children's Hospital of South Texas
San Antonio Texas, 78229, United States More Info
Site Public Contact
Contact
210-575-6240
[email protected]
Jose M. Esquilin
Principal Investigator
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78229, United States More Info
Site Public Contact
Contact
210-450-3800
[email protected]
Anne-Marie R. Langevin
Principal Investigator
Primary Children's Hospital
Salt Lake City Utah, 84113, United States More Info
Site Public Contact
Contact
801-585-5270
Matthew Dietz
Principal Investigator
University of Virginia Cancer Center
Charlottesville Virginia, 22908, United States More Info
Site Public Contact
Contact
434-243-6303
[email protected]
William C. Petersen
Principal Investigator
Inova Fairfax Hospital
Falls Church Virginia, 22042, United States More Info
Site Public Contact
Contact
703-208-6650
[email protected]
Robin Y. Dulman
Principal Investigator
Children's Hospital of The King's Daughters
Norfolk Virginia, 23507, United States More Info
Site Public Contact
Contact
757-668-7243
[email protected]
Eric J. Lowe
Principal Investigator
Virginia Commonwealth University/Massey Cancer Center
Richmond Virginia, 23298, United States More Info
Site Public Contact
Contact
[email protected]
Frances Austin
Principal Investigator
Carilion Children's
Roanoke Virginia, 24014, United States More Info
Site Public Contact
Contact
540-266-6238
[email protected]
Erwood G. Edwards
Principal Investigator
Seattle Children's Hospital
Seattle Washington, 98105, United States More Info
Site Public Contact
Contact
866-987-2000
Sarah E. Leary
Principal Investigator
Providence Sacred Heart Medical Center and Children's Hospital
Spokane Washington, 99204, United States More Info
Site Public Contact
Contact
800-228-6618
[email protected]
Judy L. Felgenhauer
Principal Investigator
Mary Bridge Children's Hospital and Health Center
Tacoma Washington, 98405, United States More Info
Site Public Contact
Contact
253-403-1461
[email protected]
Robert G. Irwin
Principal Investigator
Madigan Army Medical Center
Tacoma Washington, 98431, United States More Info
Site Public Contact
Contact
253-968-6144
[email protected]
Melissa A. Forouhar
Principal Investigator
West Virginia University Charleston Division
Charleston West Virginia, 25304, United States More Info
Site Public Contact
Contact
304-388-9944
Mohamad H. Badawi
Principal Investigator
Edwards Comprehensive Cancer Center
Huntington West Virginia, 25701, United States More Info
Site Public Contact
Contact
304-399-6566
[email protected]
Mark A. Ranalli
Principal Investigator
University of Wisconsin Carbone Cancer Center
Madison Wisconsin, 53792, United States More Info
Site Public Contact
Contact
800-622-8922
Kenneth B. De Santes
Principal Investigator
Marshfield Medical Center-Marshfield
Marshfield Wisconsin, 54449, United States More Info
Site Public Contact
Contact
800-782-8581
[email protected]
Jon M. Brandt
Principal Investigator
Children's Hospital of Wisconsin
Milwaukee Wisconsin, 53226, United States More Info
Site Public Contact
Contact
414-955-4727
[email protected]
Kerri Becktell
Principal Investigator
John Hunter Children's Hospital
Hunter Regional Mail Centre New South Wales, 2310, Australia More Info
Site Public Contact
Contact
(02) 4985 5180
Elizabeth L. Hesketh
Principal Investigator
Sydney Children's Hospital
Randwick New South Wales, 2031, Australia More Info
Site Public Contact
Contact
(02) 9382-1721
Draga Barbaric
Principal Investigator
The Children's Hospital at Westmead
Westmead New South Wales, 2145, Australia More Info
Site Public Contact
Contact
61-2-9845 1400
Bhavna Padhye
Principal Investigator
Queensland Children's Hospital
South Brisbane Queensland, 4101, Australia More Info
Site Public Contact
Contact
61 7 3068 1111
Christopher J. Fraser
Principal Investigator
Women's and Children's Hospital-Adelaide
North Adelaide South Australia, 5006, Australia More Info
Site Public Contact
Contact
(08) 8161 7327
[email protected]
Maria L. Kirby
Principal Investigator
Monash Medical Center-Clayton Campus
Clayton Victoria, 3168, Australia
Royal Children's Hospital
Parkville Victoria, 3052, Australia More Info
Site Public Contact
Contact
61 3 9345 5656
[email protected]
Martin A. Campbell
Principal Investigator
Perth Children's Hospital
Perth Western Australia, 6009, Australia More Info
Site Public Contact
Contact
[email protected]
Marianne B. Phillips
Principal Investigator
Alberta Children's Hospital
Calgary Alberta, T3B 6, Canada More Info
Site Public Contact
Contact
403-220-6898
[email protected]
Victor A. Lewis
Principal Investigator
University of Alberta Hospital
Edmonton Alberta, T6G 2, Canada More Info
Site Public Contact
Contact
780-407-8798
[email protected]
Sarah J. McKillop
Principal Investigator
British Columbia Children's Hospital
Vancouver British Columbia, V6H 3, Canada More Info
Site Public Contact
Contact
604-875-2345
David B. Dix
Principal Investigator
CancerCare Manitoba
Winnipeg Manitoba, R3E 0, Canada More Info
Site Public Contact
Contact
866-561-1026
[email protected]
Ashley Chopek
Principal Investigator
Janeway Child Health Centre
Saint John's Newfoundland and Labrador, A1B 3, Canada More Info
Site Public Contact
Contact
709-777-8727
[email protected]
Lisa A. Goodyear
Principal Investigator
IWK Health Centre
Halifax Nova Scotia, B3K 6, Canada More Info
Site Public Contact
Contact
902-470-8520
[email protected]
Craig Erker
Principal Investigator
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton Ontario, L8N 3, Canada More Info
Site Public Contact
Contact
905-521-2100
Uma H. Athale
Principal Investigator
Children's Hospital
London Ontario, N6A 5, Canada More Info
Site Public Contact
Contact
519-685-8306
Shayna M. Zelcer
Principal Investigator
Children's Hospital of Eastern Ontario
Ottawa Ontario, K1H 8, Canada More Info
Site Public Contact
Contact
613-737-7600
Donna L. Johnston
Principal Investigator
Hospital for Sick Children
Toronto Ontario, M5G 1, Canada More Info
Site Public Contact
Contact
416-813-7654
[email protected]
Daniel A. Morgenstern
Principal Investigator
The Montreal Children's Hospital of the MUHC
Montreal Quebec, H3H 1, Canada More Info
Site Public Contact
Contact
514-412-4445
[email protected]
Stephanie Mourad
Principal Investigator
Centre Hospitalier Universitaire Sainte-Justine
Montreal Quebec, H3T 1, Canada More Info
Site Public Contact
Contact
514-345-4931
[email protected]
Monia Marzouki
Principal Investigator
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke Quebec, J1H 5, Canada More Info
Site Public Contact
Contact
819-820-6480
[email protected]
Josee Brossard
Principal Investigator
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
Quebec , G1V 4, Canada More Info
Site Public Contact
Contact
418-525-4444
[email protected]
Bruno Michon
Principal Investigator
Starship Children's Hospital
Grafton Auckland, 1145, New Zealand More Info
Site Public Contact
Contact
0800 728 436
Mandy PohLui de Silva
Principal Investigator
Christchurch Hospital
Christchurch , 8011, New Zealand More Info
Site Public Contact
Contact
03 364 0640
Amanda J. Lyver
Principal Investigator
HIMA San Pablo Oncologic Hospital
Caguas , 00726, Puerto Rico
University Pediatric Hospital
San Juan , 00926, Puerto Rico More Info
Site Public Contact
Contact
787-474-0333
Maria E. Echevarria
Principal Investigator
King Faisal Specialist Hospital and Research Centre
Riyadh , 11211, Saudi Arabia More Info
Site Public Contact
Contact
011-966-1-464-7272
Afshan A. Ali
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Estimated Enrollment:

221

Study ID:

NCT04322318

Recruitment Status:

Recruiting

Sponsor:


Children's Oncology Group

How clear is this clinincal trial information?

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