Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Embryonal Rhabdomyosarcoma

Study Overview
=================
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. Radiation therapy uses high energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving vincristine, dactinomycin, and cyclophosphamide together with or without radiation therapy works in treating patients with embryonal rhabdomyosarcoma.

Detailed Description
-----------------
OBJECTIVES: Determine the progression-free survival rate in patients with low-risk embryonal rhadomyosarcoma treated with a shortened treatment schedule of vincristine, dactinomycin, and cyclophosphamide with or without radiotherapy. OUTLINE: Patients receive vincristine IV, dactinomycin IV, and cyclophosphamide IV. Patients may also undergo radiotherapy. Treatment repeats every 3 weeks for up to 8 courses (total of 24 weeks) in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.

Official Title
-----------------
Phase II Trial of Short VAC1.2 Therapy for Low-Risk A Group Patients With Rhabdomyosarcoma

Conditions
-----------------
Sarcoma

Intervention / Treatment
-----------------
* Biological: dactinomycin
* Drug: cyclophosphamide
* Drug: vincristine sulfate
* Radiation: radiation therapy


Participation Criteria
=================
Eligibility 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 I or II (N0), defined by all of the following criteria: Favorable site, including orbit, head, and neck (excluding parameningeal sites), genitourinary region (excluding bladder/prostate sites), or biliary tract Tumor any size Completely resected disease OR microscopic residual disease Lymph nodes clinically negative Stage I, clinical group III (N0), defined by all of the following criteria: Favorable site Tumor any size Gross residual disease allowed (orbit only) Lymph nodes clinically negative Stage II, clinical group I (N0, Nx), defined by all of the following criteria: Unfavorable site (any sites not listed as favorable sites) Tumor ≤ 5 cm in diameter Completely resected disease Lymph nodes clinically negative OR lymph node involvement unknown 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 Must have acceptable organ function for age No uncontrolled infection No other active malignancy No other treated malignancy within the past 5 years No hypersensitivity to study drugs No Charcot-Marie-Tooth disease No chickenpox PRIOR CONCURRENT THERAPY: Chemotherapy No prior anticancer chemotherapy Endocrine therapy Prior anticancer steroids allowed Radiotherapy No prior radiotherapy Other No concurrent pentostatin

Ages Eligible for Study
-----------------
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival as measured by Kaplan-Meier method 3 years after study entry |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival as measured by Kaplan-Meier method 3 years after study entry |  |  | 
| Progression-free survival as measured by Kaplan-Meier method during events |  |  | 
| Complete response rate (orbit, group III only) at completion of study treatment |  |  | 
| Rate of toxicity as measured by NCI-CTC v 2.0 3 years after study entry |  |  | 

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