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.
- 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.
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
Hokkaido Medical Center for Child Health and Rehabilitation, Sapporo 006-0041, Japan; Recruiting
Tooru Kudoh, MD, PhD, Phone: 81-11-691-5696
Fukushima Medical University Hospital, Fukushima 960-1295, Japan; Recruiting
Atsushi Kikuta, MD, Phone: 81-24-547-1295
Gifu University Graduate School of Medicine, Gifu 500-8705, Japan; Recruiting
Hideo Kaneko, Phone: 81-58-230-6386
Hiroshima University Hospital, Hiroshima 734-8551, Japan; Recruiting
Nishimura Shinichiro, MD, Phone: 81-82-257-5212
Kagoshima University, Kagoshima 890-8520, Japan; Recruiting
Yoshifumi Kawano, Phone: 81-99-275-5351, Email: ykawano@m3.kufm.kagoshima-u.ac.jp
Kyoto Prefectural University of Medicine, Kyoto 602-8566, Japan; Recruiting
Hajime Hosoi, Phone: 81-75-251-5571, Email: hhosoi@koto.kpu-m.ac.jp
Kyoto University Hospital, Kyoto 606-8507, Japan; Recruiting
Kenichiro Watanabe, MD, Phone: 81-75-751-3297, Email: wataken@kuhp.kyoto-u.ac.jp
Osaka City University, Osaka 545-8586, Japan; Recruiting
Kazumi Yamato, Phone: 81-6-6645-3175
Osaka General Medical Center, Osaka 558-0056, Japan; Recruiting
Keiko Yumura-Yagi, MD, Phone: 81-6-6692-1201
Saitama Children's Medical Center, Saitama 339-8551, Japan; Recruiting
Akira Kikuchi, MD, PhD, Phone: 81-48-758-1811, Email: a1091069@pref.saitama.jp
Keio University School of Medicine, Tokyo 160-8582, Japan; Recruiting
Yasuhide Morikawa, MD, Phone: 81-3-5363-2593, Email: ymorikaw@sc.itc.keio.ac.jp
National Cancer Center Hospital, Tokyo 104-0045, Japan; Recruiting
Atsushi Makimoto, Phone: 81-3-3542-2511
Nihon University Itabashi Hospital, Tokyo 173, Japan; Recruiting
Hideo Mugishima, MD, Phone: 81-3-3972-8111 ext. 2700
St. Luke's International Hospital, Tokyo 104, Japan; Recruiting
R. Hosoya, MD, Phone: 81-3-3541-5151
Toho University School of Medicine, Tokyo 143-8541, Japan; Recruiting
Akira Ohara, Phone: 81-3-3762-4151
Tokyo Medical and Dental University, Tokyo 113-8510, Japan; Recruiting
Masayuki Nagasawa, Phone: 81-3-5803-5246
Yamagata University Hospital, Yamagata 990-9585, Japan; Recruiting
Mitsui Tetsuo, MD, DMedSci, Phone: 81-23-628-5329, Email: tmitsui@med.id.yamagata-u.ac.jp
Aichi Medical University, Nagakuti, Aichi 480-1103, Japan; Recruiting
Toshinori Hori, Phone: 81-561-62-3311
Anjo Kosei Hosptial, Anjo, Aichi 446-8602, Japan; Recruiting
Yuji Miyajima, MD, Phone: 81-566-75-2111, Email: miyajima@kosei.anjo.aichi
National Hospital Orgnization Nagoya Medical Center, Nagoya, Aichi 460-0001, Japan; Recruiting
Keizo Horibe, MD, PhD, Phone: 81-52-951-1111, Email: horibek@nnh.hosp.go.jp
Ehime Prefectural Central Hospital, Matsuyama-shi, Ehime 790-0024, Japan; Recruiting
Otoh Yoshiko, Phone: 81-89-947-1111
Kurume University School of Medicine, Kurume City, Fukuoka 830-0011, Japan; Recruiting
Hiroko Inada, Phone: 81-942-31-7565
National Kyushu Cancer Center, Fukuoka-shi, Fukuoka 811-1395, Japan; Recruiting
Ryohei Yokoyama, MD, Phone: 81-92-541-3231 ext. 5070, Email: ryokoya@nk-cc.go.jp
Gifu Municipal Hospital, Gifu-shi, Gifu 500-8513, Japan; Recruiting
Akira Takao, MD, Phone: 81-58-251-1101, Email: oyuki@gmhosp.gifu.gifu.jp
Gunma Children's Medical Center, Seta-gun, Gunma 377-8577, Japan; Recruiting
Manabu Sotomatsu, MD, Phone: 81-279-52-3551, Email: sotomatsu@gcmc.pref.gunma.jp
National Hospital Organization - Medical Center of Kure, Kure, Hiroshima 737-0023, Japan; Recruiting
Takeo Tanaka, MD, PhD, Phone: 81-82-322-3111
Hokkaido University Graduate School of Medicine, Sapporo, Hokkaido 060-8638, Japan; Recruiting
Ryoji Kobayashi, MD, Phone: 81-11-706-5954
Sapporo Medical University, Sapporo, Hokkaido 060-8556, Japan; Recruiting
Nobuhiro Suzuki, MD, PhD, Phone: 81-11-611-2111
Kobe City General Hospital, Kobe, Hyogo 650, Japan; Recruiting
Ikuya Usami, Phone: 81-78-302-4321
Ibaraki Children's Hospital, Mito-shi, Ibaraki 311-4145, Japan; Recruiting
Kazutoshi Koike, Phone: 81-29-254-1151, Email: kazukoike@ibaraki-kodomo.com
University of Tsukuba, Tsukuba-city, Ibaraki 305-8575, Japan; Recruiting
Michio Kaneko, MD, PhD, Phone: 81-29-853-3094, Email: mkaneko@md.tsukuba.ac.jp
Ishikawa Prefectural Central Hospital, Kanazawa-shi, Ishikawa 920-02, Japan; Recruiting
Seiki Horita, Phone: 81-76-237-8211, Email: shorita@ipch.jp
Kanazawa Medical University, Kanazawa, Ishikawa 920-8641, Japan; Recruiting
Yutaka Saikawa, MD, PhD, Phone: 81-76-265-2314, Email: saikawa@ped.m.kanazawa-u.ac.jp
Kagoshima City Hospital, Kagoshima City, Kagoshima 892-8580, Japan; Recruiting
Kiyoshi Kawakami, Phone: 81-99-224-2101
National Center for Child Health and Development, Tokyo, Kanagawa 157-8535, Japan; Recruiting
Masa-aki Kumagai, MD, Phone: 81-3-3416-0181, Email: kumagai-ma@ncchd.go.jp
Showa University Fujigaoka Hospital, Yokohama-shi, Kanagawa 227-8502, Japan; Recruiting
K. Isoyama, Phone: 81-45-971-1151, Email: isoyama@syowa-univesity-fujigaoka.gr.jp
Yokohama City University, Yokohama, Kanagawa 236-0004, Japan; Recruiting
Hiroaki Goto, Phone: 81-45-787-2800
Miyazaki Medical College University of Miyazaki, Miyazaki-gun, Miyazaki 889-1692, Japan; Recruiting
Hiroshi Moritake, Phone: 81-98-585-0989
Nagano Children's Hospital, Toyoshina-machi, Nagano 399-8288, Japan; Recruiting
Eizaburo Ishii, Phone: 81-263-73-6700
Osaka City General Hospital, Suita-shi, Osaka 565-0871, Japan; Recruiting
Junichi Hara, Phone: 81-6-6929-1221
Osaka Medical Center and Research Institute for Maternal and Child Health, Izumi, Osaka 594-1101, Japan; Recruiting
Keisei Kawa, MD, PhD, Phone: 81-725-56-1220, Email: kawakei@mch.pref.osaka.jp
Osaka Medical College, Takatsuki City, Osaka 569-8686, Japan; Recruiting
Tomoko Kuno, Phone: 81-72-683-1221
Osaka University Graduate School of Medicine, Suita-shi, Osaka 565-0871, Japan; Recruiting
Hideaki Ohta, MD, PhD, Phone: 81-6-6879-3937, Email: ohta@ped.med.osaka-u.ac.jp
Dokkyo University School of Medicine, Koshigaya, Saitama 343-8555, Japan; Recruiting
Hitoshi Ikeda, MD, Phone: 81-489-65-1111, Email: hike@dokkyomed.ac.jp
National Defense Medical College, Tokorozawa, Saitama 359-8513, Japan; Recruiting
Kazuhiro Kogawa, Phone: 81-4-2995-1621
Shiga University of Medical Science, Otsu-shi, Shiga 520-21, Japan; Recruiting
Shigeru Ohta, MD, Phone: 81-775-48-2228, Email: ohta@belle.shiga-med.ac.jp
Shimane University Hospital, Izumo, Shimane 693-8501, Japan; Recruiting
Ken Taketani, MD, Phone: 81-853-20-2219, Email: ttaketani@med.shimane-u.ac.jp
Seirei Hamamatsu General Hospital, Hamamatsu, Shizuoka 430-8558, Japan; Recruiting
Tadashi Matsubayashi, Phone: 81-53-474-2222
