Vincristine, Dactinomycin, and Cyclophosphamide in Treating Patients With Embryonal Rhabdomyosarcoma
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma |
Biological: dactinomycin Drug: cyclophosphamide Drug: vincristine sulfate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of VAC2.2/VA Therapy for Low-Risk B Group Patients With Rhabdomyosarcoma |
- Disease-free survival at 3 years after study registration [ Designated as safety issue: No ]
- Overall survival at 3 years after study registration [ Designated as safety issue: No ]
- Toxicity by NCI CTC at 3 years after study registration [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 41 |
| Study Start Date: | May 2004 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | up to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Japan | |
| Anjo Kosei Hosptial | Recruiting |
| Anjo, Aichi, Japan, 446-8602 | |
| Contact: Yuji Miyajima, MD 81-566-75-2111 miyajima@kosei.anjo.aichi | |
| Aichi Medical University | Recruiting |
| Nagakuti, Aichi, Japan, 480-1103 | |
| Contact: Toshinori Hori 81-561-62-3311 | |
| National Hospital Orgnization Nagoya Medical Center | Recruiting |
| Nagoya, Aichi, Japan, 460-0001 | |
| Contact: Keizo Horibe, MD, PhD 81-52-951-1111 horibek@nnh.hosp.go.jp | |
| Ehime Prefectural Central Hospital | Recruiting |
| Matsuyama-shi, Ehime, Japan, 790-0024 | |
| Contact: Otoh Yoshiko 81-89-947-1111 | |
| National Kyushu Cancer Center | Recruiting |
| Fukuoka-shi, Fukuoka, Japan, 811-1395 | |
| Contact: Ryohei Yokoyama, MD 81-92-541-3231 ext. 5070 ryokoya@nk-cc.go.jp | |
| Kurume University School of Medicine | Recruiting |
| Kurume City, Fukuoka, Japan, 830-0011 | |
| Contact: Hiroko Inada 81-942-31-7565 | |
| Gifu Municipal Hospital | Recruiting |
| Gifu-shi, Gifu, Japan, 500-8513 | |
| Contact: Akira Takao, MD 81-58-251-1101 oyuki@gmhosp.gifu.gifu.jp | |
| Gunma Children's Medical Center | Recruiting |
| Seta-gun, Gunma, Japan, 377-8577 | |
| Contact: Manabu Sotomatsu, MD 81-279-52-3551 sotomatsu@gcmc.pref.gunma.jp | |
| National Hospital Organization - Medical Center of Kure | Recruiting |
| Kure, Hiroshima, Japan, 737-0023 | |
| Contact: Takeo Tanaka, MD, PhD 81-82-322-3111 | |
| Hokkaido University Graduate School of Medicine | Recruiting |
| Sapporo, Hokkaido, Japan, 060-8638 | |
| Contact: Ryoji Kobayashi, MD 81-11-706-5954 | |
| Sapporo Medical University | Recruiting |
| Sapporo, Hokkaido, Japan, 060-8556 | |
| Contact: Nobuhiro Suzuki, MD, PhD 81-11-611-2111 | |
| Kobe City General Hospital | Recruiting |
| Kobe, Hyogo, Japan, 650 | |
| Contact: Ikuya Usami 81-78-302-4321 | |
| Ibaraki Children's Hospital | Recruiting |
| Mito-shi, Ibaraki, Japan, 311-4145 | |
| Contact: Kazutoshi Koike 81-29-254-1151 kazukoike@ibaraki-kodomo.com | |
| University of Tsukuba | Recruiting |
| Tsukuba-city, Ibaraki, Japan, 305-8575 | |
| Contact: Michio Kaneko, MD, PhD 81-29-853-3094 mkaneko@md.tsukuba.ac.jp | |
| Kanazawa Medical University | Recruiting |
| Kanazawa, Ishikawa, Japan, 920-8641 | |
| Contact: Yutaka Saikawa, MD, PhD 81-76-265-2314 saikawa@ped.m.kanazawa-u.ac.jp | |
| Ishikawa Prefectural Central Hospital | Recruiting |
| Kanazawa-shi, Ishikawa, Japan, 920-02 | |
| Contact: Seiki Horita 81-76-237-8211 shorita@ipch.jp | |
| Kagoshima City Hospital | Recruiting |
| Kagoshima City, Kagoshima, Japan, 892-8580 | |
| Contact: Kiyoshi Kawakami 81-99-224-2101 | |
| National Center for Child Health and Development | Recruiting |
| Tokyo, Kanagawa, Japan, 157-8535 | |
| Contact: Masa-aki Kumagai, MD 81-3-3416-0181 kumagai-ma@ncchd.go.jp | |
| Yokohama City University | Recruiting |
| Yokohama, Kanagawa, Japan, 236-0004 | |
| Contact: Hiroaki Goto 81-45-787-2800 | |
| Showa University Fujigaoka Hospital | Recruiting |
| Yokohama-shi, Kanagawa, Japan, 227-8502 | |
| Contact: K. Isoyama 81-45-971-1151 isoyama@syowa-univesity-fujigaoka.gr.jp | |
| Miyazaki Medical College University of Miyazaki | Recruiting |
| Miyazaki-gun, Miyazaki, Japan, 889-1692 | |
| Contact: Hiroshi Moritake 81-98-585-0989 | |
| Nagano Children's Hospital | Recruiting |
| Toyoshina-machi, Nagano, Japan, 399-8288 | |
| Contact: Eizaburo Ishii 81-263-73-6700 | |
| Osaka Medical Center and Research Institute for Maternal and Child Health | Recruiting |
| Izumi, Osaka, Japan, 594-1101 | |
| Contact: Keisei Kawa, MD, PhD 81-725-56-1220 kawakei@mch.pref.osaka.jp | |
| Osaka University Graduate School of Medicine | Recruiting |
| Suita-shi, Osaka, Japan, 565-0871 | |
| Contact: Hideaki Ohta, MD, PhD 81-6-6879-3937 ohta@ped.med.osaka-u.ac.jp | |
| Osaka City General Hospital | Recruiting |
| Suita-shi, Osaka, Japan, 565-0871 | |
| Contact: Junichi Hara 81-6-6929-1221 | |
| Osaka Medical College | Recruiting |
| Takatsuki City, Osaka, Japan, 569-8686 | |
| Contact: Tomoko Kuno 81-72-683-1221 | |
| Dokkyo University School of Medicine | Recruiting |
| Koshigaya, Saitama, Japan, 343-8555 | |
| Contact: Hitoshi Ikeda, MD 81-489-65-1111 hike@dokkyomed.ac.jp | |
| National Defense Medical College | Recruiting |
| Tokorozawa, Saitama, Japan, 359-8513 | |
| Contact: Kazuhiro Kogawa 81-4-2995-1621 | |
| Shiga University of Medical Science | Recruiting |
| Otsu-shi, Shiga, Japan, 520-21 | |
| Contact: Shigeru Ohta, MD 81-775-48-2228 ohta@belle.shiga-med.ac.jp | |
| Shimane University Hospital | Recruiting |
| Izumo, Shimane, Japan, 693-8501 | |
| Contact: Ken Taketani, MD 81-853-20-2219 ttaketani@med.shimane-u.ac.jp | |
| Seirei Hamamatsu General Hospital | Recruiting |
| Hamamatsu, Shizuoka, Japan, 430-8558 | |
| Contact: Tadashi Matsubayashi 81-53-474-2222 | |
| Fukushima Medical University Hospital | Recruiting |
| Fukushima, Japan, 960-1295 | |
| Contact: Atsushi Kikuta, MD 81-24-547-1295 | |
| Gifu University Graduate School of Medicine | Recruiting |
| Gifu, Japan, 500-8705 | |
| Contact: Hideo Kaneko 81-58-230-6386 | |
| Hiroshima University Hospital | Recruiting |
| Hiroshima, Japan, 734-8551 | |
| Contact: Nishimura Shinichiro, MD 81-82-257-5212 | |
| Kagoshima University | Recruiting |
| Kagoshima, Japan, 890-8520 | |
| Contact: Yoshifumi Kawano 81-99-275-5351 ykawano@m3.kufm.kagoshima-u.ac.jp | |
| Kyoto University Hospital | Recruiting |
| Kyoto, Japan, 606-8507 | |
| Contact: Kenichiro Watanabe, MD 81-75-751-3297 wataken@kuhp.kyoto-u.ac.jp | |
| Kyoto Prefectural University of Medicine | Recruiting |
| Kyoto, Japan, 602-8566 | |
| Contact: Hajime Hosoi 81-75-251-5571 hhosoi@koto.kpu-m.ac.jp | |
| Osaka General Medical Center | Recruiting |
| Osaka, Japan, 558-0056 | |
| Contact: Keiko Yumura-Yagi, MD 81-6-6692-1201 | |
| Osaka City University | Recruiting |
| Osaka, Japan, 545-8586 | |
| Contact: Kazumi Yamato 81-6-6645-3175 | |
| Saitama Children's Medical Center | Recruiting |
| Saitama, Japan, 339-8551 | |
| Contact: Akira Kikuchi, MD, PhD 81-48-758-1811 a1091069@pref.saitama.jp | |
| Hokkaido Medical Center for Child Health and Rehabilitation | Recruiting |
| Sapporo, Japan, 006-0041 | |
| Contact: Tooru Kudoh, MD, PhD 81-11-691-5696 | |
| Keio University School of Medicine | Recruiting |
| Tokyo, Japan, 160-8582 | |
| Contact: Yasuhide Morikawa, MD 81-3-5363-2593 ymorikaw@sc.itc.keio.ac.jp | |
| National Cancer Center Hospital | Recruiting |
| Tokyo, Japan, 104-0045 | |
| Contact: Atsushi Makimoto 81-3-3542-2511 | |
| Nihon University Itabashi Hospital | Recruiting |
| Tokyo, Japan, 173 | |
| Contact: Hideo Mugishima, MD 81-3-3972-8111 ext. 2700 | |
| St. Luke's International Hospital | Recruiting |
| Tokyo, Japan, 104 | |
| Contact: R. Hosoya, MD 81-3-3541-5151 | |
| Toho University School of Medicine | Recruiting |
| Tokyo, Japan, 143-8541 | |
| Contact: Akira Ohara 81-3-3762-4151 | |
| Tokyo Medical and Dental University | Recruiting |
| Tokyo, Japan, 113-8510 | |
| Contact: Masayuki Nagasawa 81-3-5803-5246 | |
| Yamagata University Hospital | Recruiting |
| Yamagata, Japan, 990-9585 | |
| Contact: Mitsui Tetsuo, MD, DMedSci 81-23-628-5329 tmitsui@med.id.yamagata-u.ac.jp | |
| Study Chair: | Hajime Hosoi | Kyoto Prefectural University of Medicine |
| Investigator: | Ryoji Hanada, MD | Saitama Children's Medical Center |
| Investigator: | Keizo Horibe, MD, PhD | National Hospital Orgnization Nagoya Medical Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00245089 History of Changes |
| Other Study ID Numbers: | CDR0000450162, JRSG-UHA-PED03-02 |
| Study First Received: | October 25, 2005 |
| Last Updated: | July 7, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
embryonal childhood rhabdomyosarcoma embryonal-botryoid childhood rhabdomyosarcoma previously untreated childhood rhabdomyosarcoma |
Additional relevant MeSH terms:
|
Rhabdomyosarcoma Rhabdomyosarcoma, Embryonal Sarcoma Myosarcoma Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Dactinomycin Cyclophosphamide Vincristine Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Anti-Bacterial Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Myeloablative Agonists Tubulin Modulators Antimitotic Agents |
ClinicalTrials.gov processed this record on June 17, 2013