RATIONALE: Drugs used in chemotherapy, such as vincristine, dactinomycin, and cyclophosphamide, 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. PURPOSE: This phase II trial is studying how well giving vincristine, dactinomycin, and cyclophosphamide together works in treating patients with embryonal rhabdomyosarcoma.
OBJECTIVES: * Determine the progression-free survival rate in patients with low-risk embryonal rhabdomyosarcoma treated with intensive chemotherapy comprising vincristine, dactinomycin, and cyclophosphamide followed by vincristine and dactinomycin. OUTLINE: Patients receive vincristine IV, dactinomycin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vincristine IV and dactinomycin IV on day 1. Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Disease-free survival at 3 years after study registration
Overall survival at 3 years after study registration
Toxicity by NCI CTC at 3 years after study registration
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