Combination Chemotherapy and Surgery in Treating Young Patients With Wilms Tumor

Status: Recruiting
Phase: Phase 3
Diagnosis: Pediatric Wilms' Tumor
NCT ID: NCT00945009 (View complete trial on
DFCI Protocol ID: 11-476


This phase III clinical trial is studying how well combination chemotherapy and surgery work in treating young patients with Wilms tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain after surgery.


Conducting Institutions:
Dana-Farber Cancer Institute, Children's Hospital Boston, Massachusetts General Hospital

Overall PI:
Elizabeth Mullen, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Mary Huang, MD, Massachusetts General Hospital

Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP,
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

DISEASE CHARACTERISTICS: - Diagnosis of 1 of the following: - Synchronous or metachronous bilateral Wilms tumor (BWT) - Unilateral Wilms tumor (WT) AND aniridia, Beckwith-Wiedemann syndrome, idiopathic hemihypertrophy, Simpson-Golabi-Behmel syndrome, Denys-Drash syndrome, or other associated genitourinary anomalies - Multicentric WT or unilateral WT with contralateral nephrogenic rest(s) in a patient < 1 year of age - Diffuse hyperplastic perilobar nephroblastomatosis - WT arising in a solitary kidney - Patients with BWT who underwent total or partial nephrectomy at diagnosis are eligible - Previously enrolled in COG-AREN03B2 PATIENT CHARACTERISTICS: - Karnofsky performance status (PS) 50-100% (for patients > 16 years of age) or Lansky PS 50-100% (for patients ≤ 16 years of age) - Total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age - AST or ALT < 2.5 times ULN for age - Shortening fraction ≥ 27% by ECHO OR ejection fraction ≥ 50% by radionuclide angiogram - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No prior systemic chemotherapy or radiotherapy, except for patients with metachronous WT that developed in a solitary kidney after prior treatment for WT - No concurrent aprepitant
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