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

About this trial
This is an interventional treatment trial for Sarcoma focused on measuring embryonal childhood rhabdomyosarcoma, embryonal-botryoid childhood rhabdomyosarcoma, previously untreated childhood rhabdomyosarcoma
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 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
Sites / Locations
- Anjo Kosei HosptialRecruiting
- Aichi Medical UniversityRecruiting
- National Hospital Orgnization Nagoya Medical CenterRecruiting
- Ehime Prefectural Central HospitalRecruiting
- National Kyushu Cancer CenterRecruiting
- Kurume University School of MedicineRecruiting
- Gifu Municipal HospitalRecruiting
- Gunma Children's Medical CenterRecruiting
- National Hospital Organization - Medical Center of KureRecruiting
- Sapporo Medical UniversityRecruiting
- Hokkaido University Graduate School of MedicineRecruiting
- Kobe City General HospitalRecruiting
- Ibaraki Children's HospitalRecruiting
- University of TsukubaRecruiting
- Ishikawa Prefectural Central HospitalRecruiting
- Kanazawa Medical UniversityRecruiting
- Kagoshima City HospitalRecruiting
- National Center for Child Health and DevelopmentRecruiting
- Showa University Fujigaoka HospitalRecruiting
- Yokohama City UniversityRecruiting
- Miyazaki Medical College University of MiyazakiRecruiting
- Nagano Children's HospitalRecruiting
- Osaka Medical Center and Research Institute for Maternal and Child HealthRecruiting
- Osaka City General HospitalRecruiting
- Osaka University Graduate School of MedicineRecruiting
- Osaka Medical CollegeRecruiting
- Dokkyo University School of MedicineRecruiting
- National Defense Medical CollegeRecruiting
- Shiga University of Medical ScienceRecruiting
- Shimane University HospitalRecruiting
- Seirei Hamamatsu General HospitalRecruiting
- Fukushima Medical University HospitalRecruiting
- Gifu University Graduate School of MedicineRecruiting
- Hiroshima University HospitalRecruiting
- Kagoshima UniversityRecruiting
- Kyoto Prefectural University of MedicineRecruiting
- Kyoto University HospitalRecruiting
- Osaka City UniversityRecruiting
- Osaka General Medical CenterRecruiting
- Saitama Children's Medical CenterRecruiting
- Hokkaido Medical Center for Child Health and RehabilitationRecruiting
- National Cancer Center HospitalRecruiting
- St. Luke's International HospitalRecruiting
- Tokyo Medical and Dental UniversityRecruiting
- Toho University School of MedicineRecruiting
- Keio University School of MedicineRecruiting
- Nihon University Itabashi HospitalRecruiting
- Yamagata University HospitalRecruiting