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Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms' Tumor
Not Recruiting
Trial ID: NCT00379340
Purpose
This phase III trial is studying how well combination chemotherapy with or without radiation therapy works in treating young patients with newly diagnosed stage III or stage IV 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) with or without radiation therapy may kill more tumor cells.
Official Title
Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumors
Stanford Investigator(s)
Eligibility
Inclusion Criteria:
* Newly diagnosed Wilms' tumor meeting 1 of the following criteria:
* Stage IV disease with favorable histology with or without loss of heterozygosity (LOH) for 1p and 16q
* Stage III disease with favorable histology with LOH for 1p and 16q transferring from clinical trial COG-AREN0532
* Patients must begin therapy within 14 days after surgery or biopsy, unless medically contraindicated
* No bilateral Wilms' tumors (stage IV)
* Patients should be referred to COG-AREN0534
* Previously enrolled in clinical trial COG-AREN03B2
* Karnofsky performance status (PS) 50-100% (for patients \> 16 years of age) OR Lansky PS 50-100% (for patients ≤ 16 years of age)
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST or ALT \< 2.5 times ULN
* Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by radionuclide angiogram
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior tumor-directed chemotherapy or radiotherapy unless transferring from clinical trial COG-AREN0532 OR treatment for emergent issues, as medically indicated
* No concurrent aprepitant
Intervention(s):
biological: dactinomycin
drug: cyclophosphamide
drug: doxorubicin hydrochloride
drug: etoposide
procedure: conventional surgery
radiation: 3-dimensional conformal radiation therapy
drug: Vincristine Sulfate Liposome
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Peds Hem/Onc CRAs
650-723-5535