- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00245089
Vincristine, Dactinomycin, and Cyclophosphamide in Treating Patients With Embryonal Rhabdomyosarcoma
Phase II Trial of VAC2.2/VA Therapy for Low-Risk B Group Patients With Rhabdomyosarcoma
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Fukushima, Japan, 960-1295
- Recruiting
- Fukushima Medical University Hospital
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Gifu, Japan, 500-8705
- Recruiting
- Gifu University Graduate School of Medicine
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Hiroshima, Japan, 734-8551
- Recruiting
- Hiroshima University Hospital
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Kagoshima, Japan, 890-8520
- Recruiting
- Kagoshima University
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Kyoto, Japan, 606-8507
- Recruiting
- Kyoto University Hospital
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Kyoto, Japan, 602-8566
- Recruiting
- Kyoto Prefectural University of Medicine
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Osaka, Japan, 545-8586
- Recruiting
- Osaka City University
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Osaka, Japan, 558-0056
- Recruiting
- Osaka General Medical Center
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Saitama, Japan, 339-8551
- Recruiting
- Saitama Children's Medical Center
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Sapporo, Japan, 006-0041
- Recruiting
- Hokkaido Medical Center for Child Health and Rehabilitation
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Tokyo, Japan, 104-0045
- Recruiting
- National Cancer Center Hospital
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Tokyo, Japan, 160-8582
- Recruiting
- Keio University School of Medicine
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Tokyo, Japan, 104
- Recruiting
- St. Luke's International Hospital
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Tokyo, Japan, 113-8510
- Recruiting
- Tokyo Medical and Dental University
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Tokyo, Japan, 143-8541
- Recruiting
- Toho University School of Medicine
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Tokyo, Japan, 173
- Recruiting
- Nihon University Itabashi Hospital
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Yamagata, Japan, 990-9585
- Recruiting
- Yamagata University Hospital
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Aichi
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Anjo, Aichi, Japan, 446-8602
- Recruiting
- Anjo Kosei Hosptial
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Nagakuti, Aichi, Japan, 480-1103
- Recruiting
- Aichi Medical University
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Nagoya, Aichi, Japan, 460-0001
- Recruiting
- National Hospital Orgnization Nagoya Medical Center
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Ehime
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Matsuyama-shi, Ehime, Japan, 790-0024
- Recruiting
- Ehime Prefectural Central Hospital
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Fukuoka
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Fukuoka-shi, Fukuoka, Japan, 811-1395
- Recruiting
- National Kyushu Cancer Center
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Kurume City, Fukuoka, Japan, 830-0011
- Recruiting
- Kurume University School of Medicine
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Gifu
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Gifu-shi, Gifu, Japan, 500-8513
- Recruiting
- Gifu Municipal Hospital
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Gunma
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Seta-gun, Gunma, Japan, 377-8577
- Recruiting
- Gunma Children's Medical Center
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Hiroshima
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Kure, Hiroshima, Japan, 737-0023
- Recruiting
- National Hospital Organization - Medical Center of Kure
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Hokkaido
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Sapporo, Hokkaido, Japan, 060-8556
- Recruiting
- Sapporo Medical University
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Sapporo, Hokkaido, Japan, 060-8638
- Recruiting
- Hokkaido University Graduate School of Medicine
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-
Hyogo
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Kobe, Hyogo, Japan, 650
- Recruiting
- Kobe City General Hospital
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Ibaraki
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Mito-shi, Ibaraki, Japan, 311-4145
- Recruiting
- Ibaraki Children's Hospital
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Tsukuba-city, Ibaraki, Japan, 305-8575
- Recruiting
- University of Tsukuba
-
-
Ishikawa
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Kanazawa, Ishikawa, Japan, 920-8641
- Recruiting
- Kanazawa Medical University
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Kanazawa-shi, Ishikawa, Japan, 920-02
- Recruiting
- Ishikawa Prefectural Central Hospital
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Kagoshima
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Kagoshima City, Kagoshima, Japan, 892-8580
- Recruiting
- Kagoshima City Hospital
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Kanagawa
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Tokyo, Kanagawa, Japan, 157-8535
- Recruiting
- National Center for Child Health and Development
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Yokohama, Kanagawa, Japan, 236-0004
- Recruiting
- Yokohama City University
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Yokohama-shi, Kanagawa, Japan, 227-8502
- Recruiting
- Showa University Fujigaoka Hospital
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Miyazaki
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Miyazaki-gun, Miyazaki, Japan, 889-1692
- Recruiting
- Miyazaki Medical College University of Miyazaki
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Nagano
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Toyoshina-machi, Nagano, Japan, 399-8288
- Recruiting
- Nagano Children's Hospital
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Osaka
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Izumi, Osaka, Japan, 594-1101
- Recruiting
- Osaka Medical Center and Research Institute for Maternal and Child Health
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Suita-shi, Osaka, Japan, 565-0871
- Recruiting
- Osaka City General Hospital
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Suita-shi, Osaka, Japan, 565-0871
- Recruiting
- Osaka University Graduate School of Medicine
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Takatsuki City, Osaka, Japan, 569-8686
- Recruiting
- Osaka Medical College
-
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Saitama
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Koshigaya, Saitama, Japan, 343-8555
- Recruiting
- Dokkyo University School of Medicine
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Tokorozawa, Saitama, Japan, 359-8513
- Recruiting
- National Defense Medical College
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Shiga
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Otsu-shi, Shiga, Japan, 520-21
- Recruiting
- Shiga University of Medical Science
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Shimane
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Izumo, Shimane, Japan, 693-8501
- Recruiting
- Shimane University Hospital
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Shizuoka
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Hamamatsu, Shizuoka, Japan, 430-8558
- Recruiting
- Seirei Hamamatsu General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Disease-free survival at 3 years after study registration
|
Secondary Outcome Measures
Outcome Measure |
---|
Overall survival at 3 years after study registration
|
Toxicity by NCI CTC at 3 years after study registration
|
Collaborators and Investigators
Investigators
- Ryoji Hanada, MD, Saitama Children's Medical Center
- Keizo Horibe, MD, PhD, National Hospital Orgnization Nagoya Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Sarcoma
- Neoplasms, Muscle Tissue
- Myosarcoma
- Rhabdomyosarcoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Anti-Bacterial Agents
- Protein Synthesis Inhibitors
- Antibiotics, Antineoplastic
- Cyclophosphamide
- Vincristine
- Dactinomycin
Other Study ID Numbers
- JRSG-UHA-PED03-02
- CDR0000450162 (REGISTRY: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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