Vincristine, Dactinomycin, and Cyclophosphamide in Treating Patients With Embryonal Rhabdomyosarcoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Trial of VAC2.2/VA Therapy for Low-Risk B Group Patients With Rhabdomyosarcoma

Conditions
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Sarcoma

Intervention / Treatment
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* Biological: dactinomycin
* Drug: cyclophosphamide
* Drug: vincristine sulfate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: dactinomycin|nan|
|Drug: cyclophosphamide|nan|
|Drug: vincristine sulfate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival at 3 years after study registration |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival at 3 years after study registration |  |  | 
| Toxicity by NCI CTC at 3 years after study registration |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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embryonal childhood rhabdomyosarcoma, embryonal-botryoid childhood rhabdomyosarcoma, previously untreated childhood rhabdomyosarcoma