A Study Using Risk Factors to Determine Treatment for Children With Favorable Histology Wilms Tumors (FHWT)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor: Children's Oncology Group
Study ID: NCT06401330
Phase: PHASE3
Status: Recruiting

Apply to this trial

Conditions

Stage I Mixed Cell Type Kidney Wilms Tumor
Stage II Mixed Cell Type Kidney Wilms Tumor
Stage III Mixed Cell Type Kidney Wilms Tumor
Stage IV Mixed Cell Type Kidney Wilms Tumor

Eligibility Criteria

Sex: ALL
Age: N/A - 30 Years
Healthy Volunteers: Not accepted

Interventions

Bone Scan — PROCEDURE
Undergo bone scan for patients with metastatic sites outside the chest/abdomen/pelvis documented during therapy
Carboplatin — DRUG
Given IV
Computed Tomography — PROCEDURE
Undergo CT
Cyclophosphamide — DRUG
Given IV
Dactinomycin — BIOLOGICAL
Given IV
Doxorubicin — DRUG
Given IV
Etoposide — DRUG
Given IV
Irinotecan — DRUG
Given IV
Magnetic Resonance Imaging — PROCEDURE
Undergo MRI
Nephrectomy — PROCEDURE
Undergo nephrectomy
Patient Observation — OTHER
Undergo observation after nephrectomy
Positron Emission Tomography — PROCEDURE
Undergo PET for patients with metastatic sites outside the chest/abdomen/pelvis documented during therapy
Ultrasound Imaging — PROCEDURE
Undergo ultrasound
Vincristine — DRUG
Given IV
X-Ray Imaging — PROCEDURE
Undergo X-ray

Study Details

This phase III trial studies using risk factors in determining treatment for children with favorable tissue (histology) Wilms tumors (FHWT). Wilms Tumor is the most common type of kidney cancer in children, and FHWT is the most common subtype. Previous large clinical trials have established treatment plans that are likely to cure most children with FHWT, however some children still have their cancer come back (called relapse) and not all survive. Previous research has identified features of FHWT that are associated with higher or lower risks of relapse. The term "risk" refers to the chance of the cancer coming back after treatment. Using results of tumor histology tests, biology tests, and response to therapy may be able to improve treatment for children with FHWT.

Key Dates

Start date: Apr 15, 2025
Status verified: Mar 2026
Primary completion: Feb 13, 2031
Completion: Feb 13, 2031

Study Design

Enrollment: 1,656 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: Stage I, Arm I (EE-4A)
Patients receive regimen EE-4A: Dactinomycin IV over 1-5 or 10-15 minutes on day 1 of cycles 1-7 and vincristine IV on days 1, 8, \& 15 of cycles 1-3 and day 1 of cycles 4-7. Treatment repeats every 21 days for 7 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.
Experimental: Stage I, Arm II (observation)
Patients undergo observation without chemotherapy on study with ultrasounds and x-rays.
Experimental: Stage I, Arm III (DD-4A)
Patients receive regimen DD-4A: Dactinomycin IV over 1-5 or 10-15 minutes on day 1 of cycles 1, 3, 5, 7, \& 9, vincristine IV on days 1, 8, \& 15 of cycles 1-3 and day 1 of cycles 4-9, doxorubicin IV over 3-15 minutes on day 1 of cycles 2, 4, 6, \& 8. Treatment repeats every 21 days for 9 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.
Experimental: Stage I, Arm IV (UH-3)
Patients receive regimen UH-3: Vincristine IV on days 1, 8, \& 15 of cycles 1, 5, 7, 10, \& 13, and days 1 \& 8 of cycles 3, 4, 8, \& 11, doxorubicin IV 3-15 minutes on day 1 of cycles 1, 5, 7, 10, \& 13, cyclophosphamide IV over 30-60 minutes on day 1 of cycles 1, 5, 7, 10, \& 13, and days 1-4 of cycles 2, 6, 9, 12, \& 14, carboplatin IV over 15-60 minutes on day 1 of cycles 2, 6, 9, 12, and 14, etoposide IV over 60-120 minutes on days 1-4 of cycles 2, 6, 9, 12, \& 14, and irinotecan IV over 90 minutes on days 1-5 of cycles 3, 4, 8, \& 11. Treatment repeats every 21 days for 14 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.
Experimental: Stage II, Arm I (EE-4A)
Patients receive one cycle of regimen EE-4A as in STAGE I FHWT Arm I. Patients receive cycles 2-7 of regimen EE-4A as in STAGE I FHWT Arm I. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.
Experimental: Stage II, Arm II (EE-4A, VIVA)
Patients receive one cycle of regimen EE-4A as in STAGE I FHWT Arm I. Patients receive cycles 2-9 of regimen VIVA: Dactinomycin IV over 1-5 or 10-15 minutes on day 1 of cycles 3, 5, 7, \& 9, vincristine IV on days 1, 8, \& 15 of cycles 2-3 and day 1 of cycles 4-9, irinotecan IV over 90 minutes daily on days 1-5 of cycles 2, 4, 6, \& 8. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.
Experimental: Stage II, Arm III (EE-4A, DD-4A)
Patients receive one cycle of regimen EE-4A as in STAGE I FHWT Arm I. Patients receive cycles 2-9 of regimen DD-4A: Dactinomycin IV over 1-5 or 10-15 minutes on day 1 of cycles 3, 5, 7, and 9, vincristine IV on days 1, 8, and 15 of cycles 2-3 and day 1 of cycles 4-9, and doxorubicin IV over 3-15 minutes on day 1 of cycles 2, 4, 6, \& 8. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.
Experimental: Stage III, Arm I (DD-4A, EE-4A)
Patients able to undergo an upfront nephrectomy receive cycle 1 treatment of regimen DD-4A: Dactinomycin IV over 1-5 or 10-15 minutes on day 1 of cycle 1, vincristine IV on days 1, 8, \& 15 of cycle 1. Patients with standard biology receive cycles 2-7 of regimen EE-4A as in STAGE I FHWT Arm I. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.
Experimental: Stage III, Arm I-Upfront/Delayed (DD-4A, EE-4A)
Patients receive cycles 1-2 of regimen DD-4A: Dactinomycin IV over 1-5 or 10-15 minutes on day 1 of cycle 1, vincristine IV on days 1, 8, and 15 of cycles 1-2, and doxorubicin IV over 3-15 minutes on day 1 of cycle 2. Patients with standard biology and low intermediate risk histology receive cycles 3-7 of regimen EE-4A as in STAGE I FHWT Arm I above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.
Experimental: Stage III, Arm II (DD-4A)
Patients able to undergo an upfront nephrectomy receive cycle 1 treatment of regimen DD-4A: Dactinomycin IV over 1-5 or 10-15 minutes on day 1 of cycle 1, vincristine IV on days 1, 8, \& 15 of cycle 1. Patients with adverse biology receive cycle 2 treatment of regimen DD-4A as in STAGE II FHWT Arm III above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.
Experimental: Stage IV Arm V-Upfront-Delayed (DD-4A)
Patients receive cycles 1-2 of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY/DELAYED NEPHRECTOMY) above. Patients continue with regimen DD4A for up to 4 cycles, until time of delayed nephrectomy after cycle 3 or 4 of regimen DD-4A as in STAGE II FHWT Arm II above. They then undergo delayed nephrectomy after cycle 3 or 4. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.
Experimental: Stage IV Arm VA-Upfront-Delayed (DD-4A)
Patients receive cycles 5-9 (or 4-9 if nephrectomy occurred after cycle 3) of regimen DD-4A as in STAGE II FHWT Arm II above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.
Experimental: Stage IV Arm VB-Upfront-Delayed (M)
Patients receive regimen M as in STAGE III FHWT Arm IIB above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.
Experimental: Stage IV Arm VI-Upfront-Delayed (DD-4A, MVI)
Patients receive cycles 1-2 of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY/DELAYED NEPHRECTOMY) above. Patients continue with regimen MVI for up to 4 cycles, until time of delayed nephrectomy after cycles 3 or 4 of regimen MVI as in STAGE III FHWT Arm IIA above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.
Experimental: Stage IV Arm VII-Upfront-Delayed (DD-4A, M)
Patients in Stage IV Arm VII Upfront-Delayed receive cycles 1-2 of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY/DELAYED NEPHRECTOMY) above. Patients continue with regimen M for up to 4 cycles, until time of delayed nephrectomy after cycles 3 or 4 of regimen M as in STAGE III FHWT Arm IIA above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.
Experimental: Stage IV Arm VIII-Upfront-Delayed (UH-3)
Patients in Stage IV Arm VIII Upfront-Delayed receive regimen UH-3 as in STAGE I FHWT Arm IV above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.
Experimental: Stage IV Arm X-Upfront-Delayed (M)
Patients continue cycles 5-11 (or 4-11 if nephrectomy occurred after cycle 3) of regimen M as in STAGE III FHWT Arm IIB above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.
Experimental: Stage IV Extrapulmonary Arm I (DD-4A, MVI)
Patients in Stage IV Extrapulmonary Arm I receive 2 cycles of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY/DELAYED NEPHRECTOMY) above. Patients receive regimen MVI as in STAGE III FHWT Arm IIA above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial. Patients with metastatic sites outside the chest/abdomen/pelvis documented during therapy may undergo bone scan and/or PET.
Experimental: Stage IV Extrapulmonary Arm II (DD-4A, M)
Patients in Stage IV Extrapulmonary Arm II receive 2 cycles of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY/DELAYED NEPHRECTOMY) above. Patients receive regimen M as in STAGE III FHWT Arm IIB above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial. Patients with metastatic sites outside the chest/abdomen/pelvis documented during therapy may undergo bone scan and/or PET.
Experimental: Stage IV Extrapulmonary Arm III (DD-4A, MVI)
Patients in Stage IV Extrapulmonary Arm III receive 2 cycles of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY/DELAYED NEPHRECTOMY) above. Patients receive regimen MVI as in STAGE III FHWT Arm IIA above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial. Patients with metastatic sites outside the chest/abdomen/pelvis documented during therapy may undergo bone scan and/or PET.
Experimental: Stage IV Extrapulmonary Arm IV (DD-4A, M)
Patients in Stage IV Extrapulmonary Arm IV receive 2 cycles of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY/DELAYED NEPHRECTOMY) above. Patients receive regimen M as in STAGE III FHWT Arm IIB above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial. Patients with metastatic sites outside the chest/abdomen/pelvis documented during therapy may undergo bone scan and/or PET.
Experimental: Stage IV Extrapulmonary Arm IX (MVI)
Patients in Stage IV Extrapulmonary Arm IX receive cycles 5-13 (or 4-13 if nephrectomy occurred after cycle 3) of regimen MVI as in STAGE III FHWT Arm IIA above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial. Patients with metastatic sites outside the chest/abdomen/pelvis documented during therapy may undergo bone scan and/or PET.
Experimental: Stage IV Extrapulmonary Arm V (DD-4A, UH-3)
Patients in Stage IV Extrapulmonary Arm V receive 2 cycles of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY/DELAYED NEPHRECTOMY) above. Patients receive regimen UH-3 as in STAGE I FHWT Arm IV above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial. Patients with metastatic sites outside the chest/abdomen/pelvis documented during therapy may undergo bone scan and/or PET.
Experimental: Stage IV Extrapulmonary Arm VI (DD-4A, MVI)
Patients in Stage IV Extrapulmonary Arm VI receive 2 cycles of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY/DELAYED NEPHRECTOMY) above. Patients receive cycles 3-4 of regimen MVI as in STAGE III FHWT Arm IIA above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial. Patients with metastatic sites outside the chest/abdomen/pelvis documented during therapy may undergo bone scan and/or PET.
Experimental: Stage IV Extrapulmonary Arm VII (DD-4A, M)
Patients in Stage IV Extrapulmonary Arm VII receive 2 cycles of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY/DELAYED NEPHRECTOMY) above. Patients receive cycles 3-4 of regimen M as in STAGE III FHWT Arm IIB above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial. Patients with metastatic sites outside the chest/abdomen/pelvis documented during therapy may undergo bone scan and/or PET.
Experimental: Stage IV Extrapulmonary Arm VIII (UH-3)
Patients in Stage IV Extrapulmonary Arm VIII receive regimen UH-3 as in STAGE I FHWT Arm IV above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial. Patients with metastatic sites outside the chest/abdomen/pelvis documented during therapy may undergo bone scan and/or PET.
Experimental: Stage IV Extrapulmonary Arm X (M)
Patients in Stage IV Extrapulmonary Arm X receive cycles 5-11 (or 4-11 if nephrectomy occurred after cycle 3) of regimen M as in STAGE III FHWT Arm IIB above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial. Patients with metastatic sites outside the chest/abdomen/pelvis documented during therapy may undergo bone scan and/or PET.
Experimental: Stage IV Lung Metastases Arm I (DD-4A)
Patients receive cycles 1-2 of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY/DELAYED NEPHRECTOMY) above. Patients with standard biology and rapid complete lung response receive cycles 3-9 of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY/DELAYED NEPHRECTOMY) Arms V and VA above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.
Experimental: Stage IV Lung Metastases Arm II (DD-4A, MVI)
Patients receive cycles 1-2 of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY/DELAYED NEPHRECTOMY) above. Patients receive regimen MVI as in STAGE III FHWT Arm IIA above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.
Experimental: Stage IV Lung Metastases Arm III (DD-4A, M)
Patients receive cycles 1-2 of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY/DELAYED NEPHRECTOMY) above. Patients receive regimen M as in STAGE III FHWT Arm IIB above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.
Experimental: Stage IV Arm IV-Upfront-Delayed (DD-4A, M)
Patients in Stage IV Arm IV Upfront-Delayed receive cycles 1-2 of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY/DELAYED NEPHRECTOMY) above. Patients receive regimen M as in STAGE III FHWT Arm IIB above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.
Experimental: Stage IV Arm IX-Upfront-Delayed (MVI)
Patients in Stage IV Arm IX Upfront-Delayed continue cycles 5-13 (or 4-13 if nephrectomy occurred after cycle 3) of regimen MVI as in STAGE III FHWT Arm IIA above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.
Experimental: Stage III, Arm II-Upfront/Delayed (DD-4A, UH-3)
Patients receive cycles 1-2 of regimen DD-4A: Dactinomycin IV over 1-5 or 10-15 minutes on day 1 of cycle 1, vincristine IV on days 1, 8, and 15 of cycles 1-2, and doxorubicin IV over 3-15 minutes on day 1 of cycle 2. Patients receive regimen UH-3 as in STAGE I FHWT Arm IV above: Vincristine IV on days 1, 8, \& 15 of cycles 1, 5, 7, 10, \& 13, and days 1 \& 8 of cycles 3, 4, 8, \& 11, doxorubicin IV 3-15 minutes on day 1 of cycles 1, 5, 7, 10, \& 13, cyclophosphamide IV over 30-60 minutes on day 1 of cycles 1, 5, 7, 10, \& 13, and days 1-4 of cycles 2, 6, 9, 12, \& 14, carboplatin IV over 15-60 minutes on day 1 of cycles 2, 6, 9, 12, and 14, etoposide IV over 60-120 minutes on days 1-4 of cycles 2, 6, 9, 12, \& 14, and irinotecan IV over 90 minutes on days 1-5 of cycles 3, 4, 8, \& 11. Treatment repeats every 21 days for 14 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.
Experimental: Stage III, Arm IIA (MVI)
Patients receive regimen MVI: Vincristine IV on days 1, 8, \& 15 of cycle 3, days 8 \& 15 of cycle 4, and day 1 of cycles 5 \& 7-13, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of cycles 3, 7, 9, 11, \& 13, doxorubicin IV over 3-15 minutes on day 1 of cycles 3, 7, 9, 11, \& 13, cyclophosphamide IV over 15-30 minutes daily on days 1-5 of cycles 4 and 6, irinotecan IV over 90 minutes daily on days 1-5 of cycles 5, 8, 10 \& 12, and etoposide IV over 60-120 minutes daily on days 1-5 of cycles 4 and 6. Treatment repeats every 21 days for 11 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.
Experimental: Stage III, Arm IIB (M)
Patients receive regimen M: Cyclophosphamide IV over 15-30 minutes daily on days 1-5 of cycles 3, 4, 7, \& 9, etoposide IV over 60-120 minutes daily on days 1-5 of cycles 3, 4, 7, \& 9, vincristine IV on days 8 \& 15 of cycles 3 \& 4 and day 1 of cycles 5, 6, 8, 10, \& 11, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of cycles 5, 6, 8, 10, \& 11, and doxorubicin IV over 3-15 minutes of cycles 5, 6, 8, 10, \& 11.
Experimental: Stage III, Arm III-Upfront/Delayed (DD-4A, MVI)
Patients receive cycles 1-2 of regimen DD-4A: Dactinomycin IV over 1-5 or 10-15 minutes on day 1 of cycle 1, vincristine IV on days 1, 8, and 15 of cycles 1-2, and doxorubicin IV over 3-15 minutes on day 1 of cycle 2. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients receive regimen MVI as in STAGE III FHWT Arm IIA above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.
Experimental: Stage III, Arm IV-Upfront/Delayed (DD-4A, M)
Patients receive cycles 1-2 of regimen DD-4A: Dactinomycin IV over 1-5 or 10-15 minutes on day 1 of cycle 1, vincristine IV on days 1, 8, and 15 of cycles 1-2, and doxorubicin IV over 3-15 minutes on day 1 of cycle 2. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients receive regimen M as in STAGE III FHWT Arm IIB above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.
Experimental: Stage III, Arm IX-Upfront/Delayed (MVI)
Patients receive cycles 5-13 (or 4-13 if nephrectomy occurred after cycle 3) of regimen MVI as in STAGE III FHWT Arm IIA above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.
Experimental: Stage III, Arm V-Upfront/Delayed (DD-4A)
Patients receive cycles 1-2 of regimen DD-4A: Dactinomycin IV over 1-5 or 10-15 minutes on day 1 of cycle 1, vincristine IV on days 1, 8, and 15 of cycles 1-2, and doxorubicin IV over 3-15 minutes on day 1 of cycle 2. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients receive cycles 3-4 of regimen DD-4A as in STAGE II FHWT Arm III above. They then undergo delayed nephrectomy after cycle 3 or 4. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.
Experimental: Stage III, Arm VA-Upfront/Delayed (DD-4A)
Patients receive cycles 5-9 (or 4-9 if nephrectomy occurred after cycle 3) of regimen DD-4A as in STAGE II FHWT Arm III above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.
Experimental: Stage III, Arm VB-Upfront/Delayed (M)
Patients receive cycles 5-9 (or 4-9 if nephrectomy occurred after cycle 3) of regimen M as in STAGE III FHWT Arm IIB above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.
Experimental: Stage III, Arm VI-Upfront/Delayed (DD-4A, MVI)
Patients receive cycles 1-2 of regimen DD-4A: Dactinomycin IV over 1-5 or 10-15 minutes on day 1 of cycle 1, vincristine IV on days 1, 8, and 15 of cycles 1-2, and doxorubicin IV over 3-15 minutes on day 1 of cycle 2. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients receive cycles 3-4 of regimen MVI as in STAGE III FHWT Arm IIA above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.
Experimental: Stage III, Arm VII-Upfront/Delayed (DD-4A, M)
Patients receive cycles 1-2 of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY/DELAYED NEPHRECTOMY) above. Patients receive cycles 3-4 of regimen M as in STAGE III FHWT Arm IIB above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.
Experimental: Stage III, Arm VIII-Upfront/Delayed (UH-3)
Patients receive regimen UH-3 as in STAGE I FHWT Arm IV above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.
Experimental: Stage III, Arm X-Upfront/Delayed (M)
Patients receive cycles 5-11 (or 4-11 if nephrectomy occurred after cycle 3) of regimen M as in STAGE III FHWT Arm IIB above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.
Experimental: Stage IV Arm I-Upfront-Delayed (DD-4A, EE-4A)
Patients receive cycles 1-2 of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY/DELAYED NEPHRECTOMY) above. Patients receive cycles 3-9 of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY/DELAYED NEPHRECTOMY) Arms V and VA above.Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.
Experimental: Stage IV Arm II-Upfront-Delayed (DD-4A, UH-3)
Patients receive cycles 1-2 of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY/DELAYED NEPHRECTOMY) above. Patients receive regimen UH-3 as in STAGE I FHWT Arm IV above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.
Experimental: Stage IV Arm III-Upfront-Delayed (DD-4A, MVI)
Patients in Stage IV Arm III Upfront-Delayed receive cycles 1-2 of regimen DD-4A as in STAGE III FHWT (UPFRONT BIOPSY/DELAYED NEPHRECTOMY) above. Patients receive regimen MVI as in STAGE III FHWT Arm IIA above. Patients also undergo CT, CT or MRI, ultrasound, and X-ray imaging throughout the trial.

Primary Outcome Measure

Event-free survival (EFS) [ Time Frame: Up to 4 years from study entry ]

Locations (146)

Facility	City	State	ZIP	Site coordinators
Children's Hospital of Alabama	Birmingham	Alabama	35233	Site Public Contact [email protected] 205-638-9285 Jamie M. Aye (PRINCIPAL_INVESTIGATOR)
USA Health Strada Patient Care Center	Mobile	Alabama	36604	Site Public Contact 800-388-8721 Hamayun Imran (PRINCIPAL_INVESTIGATOR)
Providence Alaska Medical Center	Anchorage	Alaska	99508	Site Public Contact [email protected] 907-212-6871 Brenda J. Wittman (PRINCIPAL_INVESTIGATOR)
Banner Children's at Desert	Mesa	Arizona	85202	Site Public Contact 480-412-3100 Joseph C. Torkildson (PRINCIPAL_INVESTIGATOR)
Phoenix Childrens Hospital	Phoenix	Arizona	85016	Site Public Contact 602-546-0920 Alok K. Kothari (PRINCIPAL_INVESTIGATOR)
Arkansas Children's Hospital	Little Rock	Arkansas	72202-3591	Site Public Contact 501-364-7373 Michael W. Bishop (PRINCIPAL_INVESTIGATOR)
Kaiser Permanente Downey Medical Center	Downey	California	90242	Site Public Contact 626-564-3455 Robert M. Cooper (PRINCIPAL_INVESTIGATOR)
Loma Linda University Medical Center	Loma Linda	California	92354	Site Public Contact 909-558-4050 Albert Kheradpour (PRINCIPAL_INVESTIGATOR)
Miller Children's and Women's Hospital Long Beach	Long Beach	California	90806	Site Public Contact 562-933-5600 Jacqueline N. Casillas (PRINCIPAL_INVESTIGATOR)
Cedars-Sinai Medical Center	Los Angeles	California	90048	Site Public Contact [email protected] 310-423-2133 Leo Mascarenhas (PRINCIPAL_INVESTIGATOR)
Valley Children's Hospital	Madera	California	93636	Site Public Contact [email protected] 559-353-3000 Ruetima Titapiwatanakun (PRINCIPAL_INVESTIGATOR)
Kaiser Permanente-Oakland	Oakland	California	94611	Site Public Contact [email protected] 877-642-4691 Aarati V. Rao (PRINCIPAL_INVESTIGATOR)
UCSF Benioff Children's Hospital Oakland	Oakland	California	94609	Site Public Contact [email protected] 510-428-3264 Natalie L. Wu (PRINCIPAL_INVESTIGATOR)
Children's Hospital of Orange County	Orange	California	92868	Site Public Contact [email protected] 714-509-8646 Elyssa M. Rubin (PRINCIPAL_INVESTIGATOR)
Lucile Packard Children's Hospital Stanford University	Palo Alto	California	94304	Site Public Contact [email protected] 800-694-0012 Jay Michael S. Balagtas (PRINCIPAL_INVESTIGATOR)
University of California Davis Comprehensive Cancer Center	Sacramento	California	95817	Site Public Contact 916-734-3089 Marcio H. Malogolowkin (PRINCIPAL_INVESTIGATOR)
Rady Children's Hospital - San Diego	San Diego	California	92123	Site Public Contact 858-966-5934 William D. Roberts (PRINCIPAL_INVESTIGATOR)
UCSF Medical Center-Mission Bay	San Francisco	California	94158	Site Public Contact [email protected] 877-827-3222 Natalie L. Wu (PRINCIPAL_INVESTIGATOR)
Children's Hospital Colorado	Aurora	Colorado	80045	Site Public Contact [email protected] 303-764-5056 Sandra Luna-Fineman (PRINCIPAL_INVESTIGATOR)
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center	Denver	Colorado	80218	Site Public Contact [email protected] 303-832-2344 Florence Choo (PRINCIPAL_INVESTIGATOR)
Connecticut Children's Medical Center	Hartford	Connecticut	06106	Site Public Contact 860-545-9981 Michael S. Isakoff (PRINCIPAL_INVESTIGATOR)
Yale University	New Haven	Connecticut	06520	Site Public Contact [email protected] 203-785-5702 Farzana Pashankar (PRINCIPAL_INVESTIGATOR)
Alfred I duPont Hospital for Children	Wilmington	Delaware	19803	Site Public Contact [email protected] 302-651-5572 Vibhuti Agarwal (PRINCIPAL_INVESTIGATOR)
Children's National Medical Center	Washington D.C.	District of Columbia	20010	Site Public Contact [email protected] 202-476-2800 Jeffrey S. Dome (PRINCIPAL_INVESTIGATOR)
Broward Health Medical Center	Fort Lauderdale	Florida	33316	Site Public Contact [email protected] 302-651-5572 Hector M. Rodriguez-Cortes (PRINCIPAL_INVESTIGATOR)
Golisano Children's Hospital of Southwest Florida	Fort Myers	Florida	33908	Site Public Contact [email protected] 239-343-5333 Emad K. Salman (PRINCIPAL_INVESTIGATOR)
UF Health Cancer Institute - Gainesville	Gainesville	Florida	32610	Site Public Contact [email protected] 352-273-8010 Brian Stover (PRINCIPAL_INVESTIGATOR)
Memorial Regional Hospital/Joe DiMaggio Children's Hospital	Hollywood	Florida	33021	Site Public Contact [email protected] 954-265-1847 Iftikhar Hanif (PRINCIPAL_INVESTIGATOR)
Nemours Children's Clinic-Jacksonville	Jacksonville	Florida	32207	Site Public Contact [email protected] 302-651-5572 Vibhuti Agarwal (PRINCIPAL_INVESTIGATOR)
Nicklaus Children's Hospital	Miami	Florida	33155	Site Public Contact 888-624-2778 Maggie E. Fader (PRINCIPAL_INVESTIGATOR)
University of Miami Miller School of Medicine-Sylvester Cancer Center	Miami	Florida	33136	Site Public Contact 305-243-2647 Meghan McCormick (PRINCIPAL_INVESTIGATOR)
Arnold Palmer Hospital for Children	Orlando	Florida	32806	Site Public Contact [email protected] 321-841-5357 Jaime M. Libes-Bander (PRINCIPAL_INVESTIGATOR)
Nemours Children's Hospital	Orlando	Florida	32827	Site Public Contact [email protected] 302-651-5572 Vibhuti Agarwal (PRINCIPAL_INVESTIGATOR)
Nemours Children's Clinic - Pensacola	Pensacola	Florida	32504	Site Public Contact [email protected] Jeffrey H. Schwartz (PRINCIPAL_INVESTIGATOR)
Johns Hopkins All Children's Hospital	St. Petersburg	Florida	33701	Site Public Contact [email protected] 727-767-4784 Muaz A. Alrazzak (PRINCIPAL_INVESTIGATOR)
Saint Joseph's Hospital/Children's Hospital-Tampa	Tampa	Florida	33607	Site Public Contact [email protected] 813-357-0849 Don E. Eslin (PRINCIPAL_INVESTIGATOR)
Saint Mary's Medical Center	West Palm Beach	Florida	33407	Site Public Contact 561-822-4745 Matthew D. Ramirez (PRINCIPAL_INVESTIGATOR)
Children's Healthcare of Atlanta - Arthur M Blank Hospital	Atlanta	Georgia	30329	Site Public Contact [email protected] 404-785-0232 Kathryn S. Sutton (PRINCIPAL_INVESTIGATOR)
Augusta University Medical Center	Augusta	Georgia	30912	Site Public Contact [email protected] 706-721-2388 Colleen H. McDonough (PRINCIPAL_INVESTIGATOR)
Atrium Health Navicent	Macon	Georgia	31201	Site Public Contact [email protected] 478-633-2152 Sushmita Nair (PRINCIPAL_INVESTIGATOR)
Memorial Health University Medical Center	Savannah	Georgia	31404	Site Public Contact [email protected] 912-350-7887 Andrew L. Pendleton (PRINCIPAL_INVESTIGATOR)
Kapiolani Medical Center for Women and Children	Honolulu	Hawaii	96826	Site Public Contact 808-983-6090 Wade T. Kyono (PRINCIPAL_INVESTIGATOR)
Saint Luke's Cancer Institute - Boise	Boise	Idaho	83712	Site Public Contact [email protected] 208-381-2774 Martha M. Pacheco (PRINCIPAL_INVESTIGATOR)
Lurie Children's Hospital-Chicago	Chicago	Illinois	60611	Site Public Contact 773-880-4562 Amy L. Walz (PRINCIPAL_INVESTIGATOR)
University of Chicago Comprehensive Cancer Center	Chicago	Illinois	60637	Site Public Contact [email protected] 773-702-8222 Ami V. Desai (PRINCIPAL_INVESTIGATOR)
University of Illinois	Chicago	Illinois	60612	Site Public Contact 312-355-3046 Dipti S. Dighe (PRINCIPAL_INVESTIGATOR)
Advocate Children's Hospital-Oak Lawn	Oak Lawn	Illinois	60453	Site Public Contact 847-723-7570 Rebecca E. McFall (PRINCIPAL_INVESTIGATOR)
Advocate Children's Hospital-Park Ridge	Park Ridge	Illinois	60068	Site Public Contact [email protected] Rebecca E. McFall (PRINCIPAL_INVESTIGATOR)
Saint Jude Midwest Affiliate	Peoria	Illinois	61637	Site Public Contact 888-226-4343 Prerna Kumar (PRINCIPAL_INVESTIGATOR)
Riley Hospital for Children	Indianapolis	Indiana	46202	Site Public Contact 800-248-1199 Marissa Just (PRINCIPAL_INVESTIGATOR)
Blank Children's Hospital	Des Moines	Iowa	50309	Site Public Contact [email protected] 515-241-8912 Samantha L. Mallory (PRINCIPAL_INVESTIGATOR)
University of Iowa/Holden Comprehensive Cancer Center	Iowa City	Iowa	52242	Site Public Contact 800-237-1225 Andrew P. Groves (PRINCIPAL_INVESTIGATOR)
University of Kentucky/Markey Cancer Center	Lexington	Kentucky	40536	Site Public Contact 859-257-3379 James T. Badgett (PRINCIPAL_INVESTIGATOR)
Children's Hospital New Orleans	New Orleans	Louisiana	70118	Site Public Contact 504-894-5377 Maria C. Velez-Yanguas (PRINCIPAL_INVESTIGATOR)
Ochsner Medical Center Jefferson	New Orleans	Louisiana	70121	Site Public Contact [email protected] 504-842-8084 Craig Lotterman (PRINCIPAL_INVESTIGATOR)
Maine Children's Cancer Program	Scarborough	Maine	04074	Site Public Contact [email protected] 207-396-8670 Sei-Gyung K. Sze (PRINCIPAL_INVESTIGATOR)
Johns Hopkins University/Sidney Kimmel Cancer Center	Baltimore	Maryland	21287	Site Public Contact [email protected] 410-955-8804 Patience Odeniyide (PRINCIPAL_INVESTIGATOR)
Sinai Hospital of Baltimore	Baltimore	Maryland	21215	Site Public Contact 410-601-9083 Jason M. Fixler (PRINCIPAL_INVESTIGATOR)
University of Maryland/Greenebaum Cancer Center	Baltimore	Maryland	21201	Site Public Contact 800-888-8823 Teresa A. York (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer Institute	Boston	Massachusetts	02215	Site Public Contact 877-442-3324 Elizabeth A. Mullen (PRINCIPAL_INVESTIGATOR)
Massachusetts General Hospital Cancer Center	Boston	Massachusetts	02114	Site Public Contact 877-726-5130 Lauren H. Boal (PRINCIPAL_INVESTIGATOR)
Baystate Medical Center	Springfield	Massachusetts	01199	Site Public Contact [email protected] 413-794-3565 Joanna G. Luty (PRINCIPAL_INVESTIGATOR)
UMass Memorial Medical Center - University Campus	Worcester	Massachusetts	01655	Site Public Contact [email protected] 508-856-3216 Stefanie R. Lowas (PRINCIPAL_INVESTIGATOR)
C S Mott Children's Hospital	Ann Arbor	Michigan	48109	Site Public Contact 800-865-1125 Rama Jasty (PRINCIPAL_INVESTIGATOR)
Children's Hospital of Michigan	Detroit	Michigan	48201	Site Public Contact [email protected] Alissa M. Martin (PRINCIPAL_INVESTIGATOR)
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital	Grand Rapids	Michigan	49503	Site Public Contact [email protected] 616-391-1230 Kathleen Y. Butler (PRINCIPAL_INVESTIGATOR)
Bronson Methodist Hospital	Kalamazoo	Michigan	49007	Site Public Contact [email protected] 616-391-1230 Kathleen Y. Butler (PRINCIPAL_INVESTIGATOR)
Children's Hospitals and Clinics of Minnesota - Minneapolis	Minneapolis	Minnesota	55404	Site Public Contact [email protected] 612-813-5913 Michael K. Richards (PRINCIPAL_INVESTIGATOR)
University of Minnesota/Masonic Cancer Center	Minneapolis	Minnesota	55455	Site Public Contact 612-624-2620 Robin L. Williams (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in Rochester	Rochester	Minnesota	55905	Site Public Contact 855-776-0015 Peter Schoettler (PRINCIPAL_INVESTIGATOR)
University of Mississippi Medical Center	Jackson	Mississippi	39216	Site Public Contact 601-815-6700 Betty L. Herrington (PRINCIPAL_INVESTIGATOR)
University of Missouri Children's Hospital	Columbia	Missouri	65212	Site Public Contact [email protected] 573-882-1960 Barbara A. Gruner (PRINCIPAL_INVESTIGATOR)
Children's Mercy Hospitals and Clinics	Kansas City	Missouri	64108	Site Public Contact [email protected] 816-302-6808 Keith J. August (PRINCIPAL_INVESTIGATOR)
Cardinal Glennon Children's Medical Center	St Louis	Missouri	63104	Site Public Contact 314-268-4000 William S. Ferguson (PRINCIPAL_INVESTIGATOR)
Washington University School of Medicine	St Louis	Missouri	63110	Site Public Contact [email protected] 800-600-3606 Amy Armstrong (PRINCIPAL_INVESTIGATOR)
Children's Hospital and Medical Center of Omaha	Omaha	Nebraska	68114	Site Public Contact 402-955-3949 Jill C. Beck (PRINCIPAL_INVESTIGATOR)
University of Nebraska Medical Center	Omaha	Nebraska	68198	Site Public Contact [email protected] 402-559-6941 Jill C. Beck (PRINCIPAL_INVESTIGATOR)
Alliance for Childhood Diseases/Cure 4 the Kids Foundation	Las Vegas	Nevada	89135	Site Public Contact [email protected] 702-384-0013 Alan K. Ikeda (PRINCIPAL_INVESTIGATOR)
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center	Lebanon	New Hampshire	03756	Site Public Contact [email protected] 800-639-6918 Angela Ricci (PRINCIPAL_INVESTIGATOR)
Hackensack University Medical Center	Hackensack	New Jersey	07601	Site Public Contact 551-996-2897 Katharine Offer (PRINCIPAL_INVESTIGATOR)
Morristown Medical Center	Morristown	New Jersey	07960	Site Public Contact 973-971-5900 Kathryn L. Laurie (PRINCIPAL_INVESTIGATOR)
Jersey Shore Medical Center	Neptune City	New Jersey	07753	Site Public Contact 732-776-4240 Katharine Offer (PRINCIPAL_INVESTIGATOR)
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital	New Brunswick	New Jersey	08903	Site Public Contact 732-235-8675 Scott Moerdler (PRINCIPAL_INVESTIGATOR)
Saint Peter's University Hospital	New Brunswick	New Jersey	08901	Site Public Contact [email protected] 732-745-8600 Nibal A. Zaghloul (PRINCIPAL_INVESTIGATOR)
Newark Beth Israel Medical Center	Newark	New Jersey	07112	Site Public Contact [email protected] 973-926-7230 Teena Bhatla (PRINCIPAL_INVESTIGATOR)
Albany Medical Center	Albany	New York	12208	Site Public Contact 518-262-5513 Lauren R. Weintraub (PRINCIPAL_INVESTIGATOR)
Roswell Park Cancer Institute	Buffalo	New York	14263	Site Public Contact [email protected] 800-767-9355 Clare J. Twist (PRINCIPAL_INVESTIGATOR)
NYU Langone Hospital - Long Island	Mineola	New York	11501	Site Public Contact [email protected] 212-263-4432 Chana L. Glasser (PRINCIPAL_INVESTIGATOR)
The Steven and Alexandra Cohen Children's Medical Center of New York	New Hyde Park	New York	11040	Site Public Contact 718-470-3460 Julie I. Krystal (PRINCIPAL_INVESTIGATOR)
Laura and Isaac Perlmutter Cancer Center at NYU Langone	New York	New York	10016	Site Public Contact [email protected] Elizabeth A. Raetz (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer Center	New York	New York	10065	Site Public Contact 212-639-7592 Michael V. Ortiz (PRINCIPAL_INVESTIGATOR)
University of Rochester	Rochester	New York	14642	Site Public Contact 585-275-5830 Rafi R. Kazi (PRINCIPAL_INVESTIGATOR)
Stony Brook University Medical Center	Stony Brook	New York	11794	Site Public Contact 800-862-2215 Laura E. Hogan (PRINCIPAL_INVESTIGATOR)
State University of New York Upstate Medical University	Syracuse	New York	13210	Site Public Contact 315-464-5476 Melanie A. Comito (PRINCIPAL_INVESTIGATOR)
New York Medical College	Valhalla	New York	10595	Site Public Contact 914-594-3794 Jessica C. Hochberg (PRINCIPAL_INVESTIGATOR)
UNC Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina	27599	Site Public Contact [email protected] 877-668-0683 Thomas B. Alexander (PRINCIPAL_INVESTIGATOR)
Carolinas Medical Center/Levine Cancer Institute	Charlotte	North Carolina	28203	Site Public Contact 800-804-9376 Joel A. Kaplan (PRINCIPAL_INVESTIGATOR)
Novant Health Presbyterian Medical Center	Charlotte	North Carolina	28204	Site Public Contact [email protected] 980-201-6360 Holly Edington (PRINCIPAL_INVESTIGATOR)
Duke University Medical Center	Durham	North Carolina	27710	Site Public Contact 888-275-3853 Jessica M. Sun (PRINCIPAL_INVESTIGATOR)
East Carolina University	Greenville	North Carolina	27834	Site Public Contact [email protected] 252-744-1015 Andrea R. Whitfield (PRINCIPAL_INVESTIGATOR)
Wake Forest University Health Sciences	Winston-Salem	North Carolina	27157	Site Public Contact 336-713-6771 Sarah Supples (PRINCIPAL_INVESTIGATOR)
Children's Hospital Medical Center of Akron	Akron	Ohio	44308	Site Public Contact 330-543-3193 Erin Wright (PRINCIPAL_INVESTIGATOR)
Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	45229	Site Public Contact [email protected] 513-636-2799 Katherine M. Somers (PRINCIPAL_INVESTIGATOR)
Rainbow Babies and Childrens Hospital	Cleveland	Ohio	44106	Site Public Contact 216-844-5437 Duncan S. Stearns (PRINCIPAL_INVESTIGATOR)
Dayton Children's Hospital	Dayton	Ohio	45404	Site Public Contact 800-228-4055 Jordan M. Wright (PRINCIPAL_INVESTIGATOR)
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital	Toledo	Ohio	43606	Site Public Contact [email protected] 419-824-1842 Jamie L. Dargart (PRINCIPAL_INVESTIGATOR)
University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	73104	Site Public Contact [email protected] 405-271-8777 Rene Y. McNall-Knapp (PRINCIPAL_INVESTIGATOR)
Legacy Emanuel Children's Hospital	Portland	Oregon	97227	Site Public Contact 503-413-2560 Jason M. Glover (PRINCIPAL_INVESTIGATOR)
Oregon Health and Science University	Portland	Oregon	97239	Site Public Contact [email protected] 503-494-1080 Katrina Winsnes (PRINCIPAL_INVESTIGATOR)
Geisinger Medical Center	Danville	Pennsylvania	17822	Site Public Contact [email protected] 570-271-5251 Jagadeesh Ramdas (PRINCIPAL_INVESTIGATOR)
Penn State Children's Hospital	Hershey	Pennsylvania	17033	Site Public Contact 717-531-6012 Lisa M. McGregor (PRINCIPAL_INVESTIGATOR)
Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	19104	Site Public Contact [email protected] 267-425-5544 Nicholas F. Evageliou (PRINCIPAL_INVESTIGATOR)
Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania	15224	Site Public Contact [email protected] 412-692-8570 Brittani K. Seynnaeve (PRINCIPAL_INVESTIGATOR)
Rhode Island Hospital	Providence	Rhode Island	02903	Site Public Contact 401-444-1488 Bradley DeNardo (PRINCIPAL_INVESTIGATOR)
Prisma Health Richland Hospital	Columbia	South Carolina	29203	Site Public Contact [email protected] 864-522-4317 Stuart L. Cramer (PRINCIPAL_INVESTIGATOR)
BI-LO Charities Children's Cancer Center	Greenville	South Carolina	29605	Site Public Contact [email protected] 864-522-4317 Aniket Saha (PRINCIPAL_INVESTIGATOR)
Sanford USD Medical Center - Sioux Falls	Sioux Falls	South Dakota	57117-5134	Site Public Contact [email protected] 605-312-3320 Kayelyn J. Wagner (PRINCIPAL_INVESTIGATOR)
T C Thompson Children's Hospital	Chattanooga	Tennessee	37403	Site Public Contact 423-778-7289 Benjamin A. Mixon (PRINCIPAL_INVESTIGATOR)
East Tennessee Childrens Hospital	Knoxville	Tennessee	37916	Site Public Contact 865-541-8266 Susan E. Spiller (PRINCIPAL_INVESTIGATOR)
Saint Jude Children's Research Hospital	Memphis	Tennessee	38105	Site Public Contact [email protected] 888-226-4343 Dylan Graetz (PRINCIPAL_INVESTIGATOR)
Vanderbilt University/Ingram Cancer Center	Nashville	Tennessee	37232	Site Public Contact 800-811-8480 Daniel J. Benedetti (PRINCIPAL_INVESTIGATOR)
Texas Tech University Health Sciences Center-Amarillo	Amarillo	Texas	79106	Site Public Contact 806-354-5411 Smita Bhaskaran (PRINCIPAL_INVESTIGATOR)
Dell Children's Medical Center of Central Texas	Austin	Texas	78723	Site Public Contact [email protected] 512-628-1902 Shannon M. Cohn (PRINCIPAL_INVESTIGATOR)
Driscoll Children's Hospital	Corpus Christi	Texas	78411	Site Public Contact [email protected] 361-694-5311 Nkechi I. Mba (PRINCIPAL_INVESTIGATOR)
Medical City Dallas Hospital	Dallas	Texas	75230	Site Public Contact 972-566-5588 Maurizio L. Ghisoli (PRINCIPAL_INVESTIGATOR)
UT Southwestern/Simmons Cancer Center-Dallas	Dallas	Texas	75390	Site Public Contact [email protected] 214-648-7097 Arhanti Sadanand (PRINCIPAL_INVESTIGATOR)
Cook Children's Medical Center	Fort Worth	Texas	76104	Site Public Contact [email protected] 682-885-2103 Kelly L. Vallance (PRINCIPAL_INVESTIGATOR)
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center	Houston	Texas	77030	Site Public Contact [email protected] 713-798-1354 Stephanie Fetzko (PRINCIPAL_INVESTIGATOR)
Covenant Children's Hospital	Lubbock	Texas	79410	Site Public Contact [email protected] 806-725-8657 Kishor M. Bhende (PRINCIPAL_INVESTIGATOR)
UMC Cancer Center / UMC Health System	Lubbock	Texas	79415	Site Public Contact 806-775-8590 Erin K. Barr (PRINCIPAL_INVESTIGATOR)
Children's Hospital of San Antonio	San Antonio	Texas	78207	Site Public Contact [email protected] 210-704-2894 Julie Voeller (PRINCIPAL_INVESTIGATOR)
Methodist Children's Hospital of South Texas	San Antonio	Texas	78229	Site Public Contact [email protected] 210-575-6240 Jose M. Esquilin (PRINCIPAL_INVESTIGATOR)
University of Texas Health Science Center at San Antonio	San Antonio	Texas	78229	Site Public Contact [email protected] 210-450-3800 Aaron J. Sugalski (PRINCIPAL_INVESTIGATOR)
Primary Children's Hospital	Salt Lake City	Utah	84113	Site Public Contact 801-585-5270 Mary J. Underdown (PRINCIPAL_INVESTIGATOR)
University of Vermont and State Agricultural College	Burlington	Vermont	05405	Site Public Contact [email protected] 802-656-8990 Jessica L. Heath (PRINCIPAL_INVESTIGATOR)
University of Virginia Cancer Center	Charlottesville	Virginia	22908	Site Public Contact [email protected] 434-243-6303 Brian C. Belyea (PRINCIPAL_INVESTIGATOR)
Inova Fairfax Hospital	Falls Church	Virginia	22042	Site Public Contact [email protected] 703-208-6650 Robin Y. Dulman (PRINCIPAL_INVESTIGATOR)
Children's Hospital of The King's Daughters	Norfolk	Virginia	23507	Site Public Contact [email protected] 757-668-7243 Melissa S. Mark (PRINCIPAL_INVESTIGATOR)
VCU Massey Comprehensive Cancer Center	Richmond	Virginia	23298	Site Public Contact [email protected] 804-628-6430 Frances Austin (PRINCIPAL_INVESTIGATOR)
Carilion Children's	Roanoke	Virginia	24014	Site Public Contact [email protected] 540-266-6238 Erwood G. Edwards (PRINCIPAL_INVESTIGATOR)
Seattle Children's Hospital	Seattle	Washington	98105	Site Public Contact 866-987-2000 Sarah E. Leary (PRINCIPAL_INVESTIGATOR)
Providence Sacred Heart Medical Center and Children's Hospital	Spokane	Washington	99204	Site Public Contact [email protected] 800-228-6618 Judy L. Felgenhauer (PRINCIPAL_INVESTIGATOR)
Mary Bridge Children's Hospital and Health Center	Tacoma	Washington	98405	Site Public Contact [email protected] 253-403-1461 Robert G. Irwin (PRINCIPAL_INVESTIGATOR)
Saint Vincent Hospital Cancer Center Green Bay	Green Bay	Wisconsin	54301	Site Public Contact [email protected] 920-433-8889 Catherine A. Long (PRINCIPAL_INVESTIGATOR)
University of Wisconsin Carbone Cancer Center - University Hospital	Madison	Wisconsin	53792	Site Public Contact [email protected] 800-622-8922 Margo L. Hoover-Regan (PRINCIPAL_INVESTIGATOR)
Children's Hospital of Wisconsin	Milwaukee	Wisconsin	53226	Site Public Contact [email protected] 414-955-4727 Kerri Becktell (PRINCIPAL_INVESTIGATOR)

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