Spots Global Cancer Trial Database for Vincristine, Dactinomycin, and Cyclophosphamide in Treating Patients With Embryonal Rhabdomyosarcoma
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Trial Identification
Brief Title: Vincristine, Dactinomycin, and Cyclophosphamide in Treating Patients With Embryonal Rhabdomyosarcoma
Official Title: Phase II Trial of VAC2.2/VA Therapy for Low-Risk B Group Patients With Rhabdomyosarcoma
Study ID: NCT00245089
Conditions
Study Description
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.
Eligibility
Minimum Age:
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Locations
Anjo Kosei Hosptial, Anjo, Aichi, Japan
Aichi Medical University, Nagakuti, Aichi, Japan
National Hospital Orgnization Nagoya Medical Center, Nagoya, Aichi, Japan
Ehime Prefectural Central Hospital, Matsuyama-shi, Ehime, Japan
National Kyushu Cancer Center, Fukuoka-shi, Fukuoka, Japan
Kurume University School of Medicine, Kurume City, Fukuoka, Japan
Gifu Municipal Hospital, Gifu-shi, Gifu, Japan
Gunma Children's Medical Center, Seta-gun, Gunma, Japan
National Hospital Organization - Medical Center of Kure, Kure, Hiroshima, Japan
Sapporo Medical University, Sapporo, Hokkaido, Japan
Hokkaido University Graduate School of Medicine, Sapporo, Hokkaido, Japan
Kobe City General Hospital, Kobe, Hyogo, Japan
Ibaraki Children's Hospital, Mito-shi, Ibaraki, Japan
University of Tsukuba, Tsukuba-city, Ibaraki, Japan
Ishikawa Prefectural Central Hospital, Kanazawa-shi, Ishikawa, Japan
Kanazawa Medical University, Kanazawa, Ishikawa, Japan
Kagoshima City Hospital, Kagoshima City, Kagoshima, Japan
National Center for Child Health and Development, Tokyo, Kanagawa, Japan
Showa University Fujigaoka Hospital, Yokohama-shi, Kanagawa, Japan
Yokohama City University, Yokohama, Kanagawa, Japan
Miyazaki Medical College University of Miyazaki, Miyazaki-gun, Miyazaki, Japan
Nagano Children's Hospital, Toyoshina-machi, Nagano, Japan
Osaka Medical Center and Research Institute for Maternal and Child Health, Izumi, Osaka, Japan
Osaka City General Hospital, Suita-shi, Osaka, Japan
Osaka University Graduate School of Medicine, Suita-shi, Osaka, Japan
Osaka Medical College, Takatsuki City, Osaka, Japan
Dokkyo University School of Medicine, Koshigaya, Saitama, Japan
National Defense Medical College, Tokorozawa, Saitama, Japan
Shiga University of Medical Science, Otsu-shi, Shiga, Japan
Shimane University Hospital, Izumo, Shimane, Japan
Seirei Hamamatsu General Hospital, Hamamatsu, Shizuoka, Japan
Fukushima Medical University Hospital, Fukushima, , Japan
Gifu University Graduate School of Medicine, Gifu, , Japan
Hiroshima University Hospital, Hiroshima, , Japan
Kagoshima University, Kagoshima, , Japan
Kyoto Prefectural University of Medicine, Kyoto, , Japan
Kyoto University Hospital, Kyoto, , Japan
Osaka City University, Osaka, , Japan
Osaka General Medical Center, Osaka, , Japan
Saitama Children's Medical Center, Saitama, , Japan
Hokkaido Medical Center for Child Health and Rehabilitation, Sapporo, , Japan
National Cancer Center Hospital, Tokyo, , Japan
St. Luke's International Hospital, Tokyo, , Japan
Tokyo Medical and Dental University, Tokyo, , Japan
Toho University School of Medicine, Tokyo, , Japan
Keio University School of Medicine, Tokyo, , Japan
Nihon University Itabashi Hospital, Tokyo, , Japan
Yamagata University Hospital, Yamagata, , Japan
Contact Details
Name: Hajime Hosoi
Affiliation: Kyoto Prefectural University of Medicine
Role: STUDY_CHAIR
Name: Ryoji Hanada, MD
Affiliation: Saitama Children's Medical Center
Role:
Name: Keizo Horibe, MD, PhD
Affiliation: National Hospital Orgnization Nagoya Medical Center
Role:
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