Sarcoma
Conditions
Keywords
embryonal childhood rhabdomyosarcoma, embryonal-botryoid childhood rhabdomyosarcoma, previously untreated childhood rhabdomyosarcoma
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALdactinomycin
DRUGcyclophosphamide
DRUGvincristine sulfate
Sponsors
Japan Rhabdomyosarcoma Study Group
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Diagnosis of embryonal rhabdomyosarcoma * Primary operation for pathological diagnosis within the past 42 days * The following variants are eligible: * Botryoid * Spindle cell * Anaplastic * Meets 1 of the following stage criteria: * Stage I, clinical group II (N1) * Favorable site * Any tumor size * Microscopic residual disease * Lymph nodes clinically positive * Stage I, clinical group III (N1) * Favorable site (orbit only) * Any tumor size * Gross residual disease * Lymph nodes clinically positive * Stage I, clinical group III (N0, NX, N1) * Favorable site (except orbit) * Any tumor size * Gross residual disease * Lymph nodes clinically negative, involvement unknown, or positive * Stage II, clinical group II (N0, NX) * Unfavorable site * Small tumor (≤ 5 cm in diameter) * Microscopic residual disease * Stage III, clinical group I or II (N0, NX, N1) * Unfavorable site * Small tumor (≤ 5 cm in diameter) with positive nodes or large tumor (\> 5 cm in diameter) with any lymph nodes status * Completely resected or microscopic residual disease PATIENT CHARACTERISTICS: Performance status * 0-3 Life expectancy * Not specified Hematopoietic * WBC ≥ 2,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 7.5 g/dL Hepatic * SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) * Bilirubin ≤ 2.5 times ULN * Bile acid ≤ 2.5 times ULN Renal * Creatinine based on age as follows: * ≤ 0.8 mg/dL (for patients \< 5 years of age) * ≤ 1.2 mg/dL (for patients 5-9 years of age) * ≤ 1.5 mg/dL (for patients ≥ 10 years of age) Cardiovascular * No severe heart disease Other * Not pregnant or nursing * No uncontrolled infection * Must have acceptable organ function for age * No other malignancy within the past 5 years * No hypersensitivity attributed to study drugs * No Charcot-Marie-Tooth disease or chickenpox PRIOR CONCURRENT THERAPY: Chemotherapy * No prior anticancer chemotherapy Endocrine therapy * Prior anticancer steroids allowed Radiotherapy * Prior emergency radiotherapy allowed within the past 2 weeks Other * No concurrent pentostatin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival at 3 years after study registration | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity by NCI CTC at 3 years after study registration | — |
| Overall survival at 3 years after study registration | — |
Countries
Japan
Outcome results
None listed