Current Research: Pediatric Hematology-Oncology

AREN0532-- Treatment for Very Low and Standard Risk Favorable Histology Wilms Tumor

Drugs used in chemotherapy, such as vincristine, dactinomycin, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving these treatments after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient.

This phase III trial is studying vincristine, dactinomycin, and doxorubicin with or without radiation therapy or observation only to see how well they work in treating patients undergoing surgery for newly diagnosed stage I, stage II, or stage III Wilms' tumor.

Eligibility

Patients may be eligible for this trial if:

• Patients must be less than 30 years of age at the time of diagnosis.
• Patients must have previously enrolled on AREN0B32 and be found to have newly diagnosed Stage I-III avorable histology Wilms tumor, confirmed by central pathology, surgical and radiology review.
• The Karnofsky performance status must be ≥ 50 for patients >16 years of age and the Lansky performance status must be ≥ 50 for patients ≤ 16 years of age.
• No prior tumor-directed chemotherapy or radiotherapy is acceptable, except if previously treated with EE-4A and enrolling from AREN03B2 with Stage I or II Favorable Histology Wilms tumor found to have LOH 1p and 16q.
• Note: Patients will be assigned through AREN03B2 to a stratum based on an “initial risk” classification determined by clinical, radiological, surgical and pathological characteristics. Treatment will be initiated based on this “initial risk” classification. By three weeks, a “final risk” classification will be assigned based on LOH findings and this “final risk” stratification will be used for assigning continuing treatment. Investigators will be notified of this final stratification.

Trial Sponsor

• Children’s Oncology Group (COG); National Cancer Institute (NCI)

Project Begin Date

• Mar 2007

Tentative Project End Date

• Feb 2011

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Revised March 30, 2009.   Please send comments, suggestions or questions about this page to Goldei Posey, gposey@mcg.edu .