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Phase II Study of Intensive Chemotherapy Comprising Vincristine, Dactinomycin, and Cyclophosphamide Followed By Vincristine and Dactinomycin in Patients With Lower-Risk Embryonal Rhabdomyosarcoma
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Alternate Title
Vincristine, Dactinomycin, and Cyclophosphamide in Treating Patients With Embryonal Rhabdomyosarcoma
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase II | Treatment | Active | Under 18 | JRSG-UHA-PED03-02
NCT00245089 |
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.
Entry 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
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
Patient Characteristics:
Performance status Life expectancy Hematopoietic - WBC ≥ 2,000/mm3
- Platelet count ≥ 100,000/mm3
- 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 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
Expected Enrollment 41A total of 41 patients will be accrued for this study. Outcomes Primary Outcome(s)Disease-free survival at 3 years after study registration
Secondary Outcome(s)Overall survival at 3 years after study registration
Toxicity by NCI CTC at 3 years after study registration
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.
Trial Contact Information
Trial Lead Organizations Japan Rhabdomyosarcoma Study Group | | | | Hajime Hosoi, Protocol chair | | | | | Ryoji Hanada, MD, Protocol co-chair | | | | | Keizo Horibe, MD, PhD, Protocol co-chair | | | |
Trial Sites
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| Japan |
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Sapporo |
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| | | | Hokkaido Medical Center for Child Health and Rehabilitation |
| | | Tooru Kudoh, MD, PhD | |
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| Aichi |
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Anjo |
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| | | | Anjo Kosei Hosptial |
| | | Yuji Miyajima, MD | |
| | Email:
miyajima@kosei.anjo.aichi |
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Nagakuti |
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| | | Aichi Medical University |
| | | Toshinori Hori | |
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Nagoya |
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| | | National Hospital Orgnization Nagoya Medical Center |
| | | Keizo Horibe, MD, PhD | |
| | Email:
horibek@nnh.hosp.go.jp |
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| Ehime |
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Matsuyama-shi |
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| | | | Ehime Prefectural Central Hospital |
| | | Otoh Yoshiko | |
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| Fukuoka |
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Fukuoka-shi |
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| | | | National Kyushu Cancer Center |
| | | Ryohei Yokoyama, MD | | Ph: | 81-92-541-3231 ext. 5070 | | |
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| | Email:
ryokoya@nk-cc.go.jp |
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Kurume City |
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| | | Kurume University School of Medicine |
| | | Hiroko Inada | |
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| Fukushima |
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Fukushima |
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| | | | Fukushima Medical University Hospital |
| | | Atsushi Kikuta, MD | |
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| Gifu |
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Gifu |
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| | | | Gifu University Graduate School of Medicine |
| | | Hideo Kaneko | |
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Gifu-shi |
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| | | Gifu Municipal Hospital |
| | | Akira Takao, MD | |
| | Email:
oyuki@gmhosp.gifu.gifu.jp |
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| Gunma |
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Seta-gun |
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| | | | Gunma Children's Medical Center |
| | | Manabu Sotomatsu, MD | |
| | Email:
sotomatsu@gcmc.pref.gunma.jp |
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| Hiroshima |
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Hiroshima |
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| | | | Hiroshima University Hospital |
| | | Nishimura Shinichiro, MD | |
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Kure |
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| | | National Hospital Organization - Medical Center of Kure |
| | | Takeo Tanaka, MD, PhD | |
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| Hokkaido |
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Sapporo |
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| | | | Hokkaido University Graduate School of Medicine |
| | | Ryoji Kobayashi, MD | |
| | | Sapporo Medical University |
| | | Nobuhiro Suzuki, MD, PhD | |
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| Hyogo |
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Kobe |
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| | | | Kobe City General Hospital |
| | | Ikuya Usami | |
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| Ibaraki |
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Mito-shi |
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| | | | Ibaraki Children's Hospital |
| | | Kazutoshi Koike | |
| | Email:
kazukoike@ibaraki-kodomo.com |
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Tsukuba-city |
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| | | University of Tsukuba |
| | | Michio Kaneko, MD, PhD | |
| | Email:
mkaneko@md.tsukuba.ac.jp |
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| Ishikawa |
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Kanazawa |
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| | | | Kanazawa Medical University |
| | | Yutaka Saikawa, MD, PhD | |
| | Email:
saikawa@ped.m.kanazawa-u.ac.jp |
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Kanazawa-shi |
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| | | Ishikawa Prefectural Central Hospital |
| | | Seiki Horita | |
| | Email:
shorita@ipch.jp |
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| Kagoshima |
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Kagoshima |
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| | | | Kagoshima University |
| | | Yoshifumi Kawano | |
| | Email:
ykawano@m3.kufm.kagoshima-u.ac.jp |
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Kagoshima City |
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| | | Kagoshima City Hospital |
| | | Kiyoshi Kawakami | |
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| Kanagawa |
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Tokyo |
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| | | | National Center for Child Health and Development |
| | | Masa-aki Kumagai, MD | |
| | Email:
kumagai-ma@ncchd.go.jp |
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Yokohama |
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| | | Yokohama City University |
| | | Hiroaki Goto | |
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Yokohama-shi |
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| | | Showa University Fujigaoka Hospital |
| | | K. Isoyama | |
| | Email:
isoyama@syowa-univesity-fujigaoka.gr.jp |
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| Kyoto |
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Kyoto |
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| | | | Kyoto Prefectural University of Medicine |
| | | Hajime Hosoi | |
| | Email:
hhosoi@koto.kpu-m.ac.jp |
| | | Kyoto University Hospital |
| | | Kenichiro Watanabe, MD | |
| | Email:
wataken@kuhp.kyoto-u.ac.jp |
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| Miyazaki |
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Miyazaki-gun |
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| | | | Miyazaki Medical College University of Miyazaki |
| | | Hiroshi Moritake | |
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| Nagano |
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Toyoshina-machi |
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| | | | Nagano Children's Hospital |
| | | Eizaburo Ishii | |
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| Osaka |
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Izumi |
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| | | | Osaka Medical Center and Research Institute for Maternal and Child Health |
| | | Keisei Kawa, MD, PhD | |
| | Email:
kawakei@mch.pref.osaka.jp |
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Osaka |
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| | | Osaka City University |
| | | Kazumi Yamato | |
| | | Osaka General Medical Center |
| | | Keiko Yumura-Yagi, MD | |
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Suita-shi |
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| | | Osaka City General Hospital |
| | | Junichi Hara | |
| | | Osaka University Graduate School of Medicine |
| | | Hideaki Ohta, MD, PhD | |
| | Email:
ohta@ped.med.osaka-u.ac.jp |
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Takatsuki City |
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| | | Osaka Medical College |
| | | Tomoko Kuno | |
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| Saitama |
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Koshigaya |
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| | | | Dokkyo University School of Medicine |
| | | Hitoshi Ikeda, MD | |
| | Email:
hike@dokkyomed.ac.jp |
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Saitama |
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| | | Saitama Children's Medical Center |
| | | Akira Kikuchi, MD, PhD | |
| | Email:
a1091069@pref.saitama.jp |
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Tokorozawa |
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| | | National Defense Medical College |
| | | Kazuhiro Kogawa | |
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| Shiga |
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Otsu-shi |
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| | | | Shiga University of Medical Science |
| | | Shigeru Ohta, MD | |
| | Email:
ohta@belle.shiga-med.ac.jp |
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| Shimane |
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Izumo |
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| | | | Shimane University Hospital |
| | | Ken Taketani, MD | |
| | Email:
ttaketani@med.shimane-u.ac.jp |
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| Shizuoka |
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Hamamatsu |
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| | | | Seirei Hamamatsu General Hospital |
| | | Tadashi Matsubayashi | |
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| Tokyo |
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Tokyo |
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| | | | Keio University School of Medicine |
| | | Yasuhide Morikawa, MD | |
| | Email:
ymorikaw@sc.itc.keio.ac.jp |
| | | National Cancer Center Hospital |
| | | Atsushi Makimoto | |
| | | Nihon University Itabashi Hospital |
| | | Hideo Mugishima, MD | | Ph: | 81-3-3972-8111 ext. 2700 | | |
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| | | St. Luke's International Hospital |
| | | R. Hosoya, MD | |
| | | Toho University School of Medicine |
| | | Akira Ohara | |
| | | Tokyo Medical and Dental University |
| | | Masayuki Nagasawa | |
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| Yamagata |
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Yamagata |
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| | | | Yamagata University Hospital |
| | | Mitsui Tetsuo, MD, DMedSci | |
| | Email:
tmitsui@med.id.yamagata-u.ac.jp |
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| Registry Information | | | Official Title | | Phase II Trial of VAC2.2/VA Therapy for Low-Risk B Group Patients with Rhabdomyosarcoma | | | Trial Start Date | | 2004-05-01 | | | Trial Completion Date | | 2011-04-30 (estimated) | | | Registered in ClinicalTrials.gov | | NCT00245089 | | | Date Submitted to PDQ | | 2005-10-19 | | | Information Last Verified | | 2008-12-28 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
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