Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Embryonal Rhabdomyosarcoma

NCT00245141 | Unknown Phase 2

• 2 other identifiers: JRSG-UHA-PED03-01CDR0000453316
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 51

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. Radiation therapy uses high energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving vincristine, dactinomycin, and cyclophosphamide together with or without radiation therapy works in treating patients with embryonal rhabdomyosarcoma.

Conditions

Sarcoma

Keywords

embryonal childhood rhabdomyosarcoma; embryonal-botryoid childhood rhabdomyosarcoma; previously untreated childhood rhabdomyosarcoma

Outcome Measures

Primary Outcomes (1)

• Disease-free survival as measured by Kaplan-Meier method 3 years after study entry

Secondary Outcomes (4)

• Overall survival as measured by Kaplan-Meier method 3 years after study entry

• Progression-free survival as measured by Kaplan-Meier method during events

• Complete response rate (orbit, group III only) at completion of study treatment

• Rate of toxicity as measured by NCI-CTC v 2.0 3 years after study entry

Interventions

dactinomycin BIOLOGICAL

cyclophosphamide DRUG

vincristine sulfate DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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 I or II (N0), defined by all of the following criteria: * Favorable site, including orbit, head, and neck (excluding parameningeal sites), genitourinary region (excluding bladder/prostate sites), or biliary tract * Tumor any size * Completely resected disease OR microscopic residual disease * Lymph nodes clinically negative * Stage I, clinical group III (N0), defined by all of the following criteria: * Favorable site * Tumor any size * Gross residual disease allowed (orbit only) * Lymph nodes clinically negative * Stage II, clinical group I (N0, Nx), defined by all of the following criteria: * Unfavorable site (any sites not listed as favorable sites) * Tumor ≤ 5 cm in diameter * Completely resected disease * Lymph nodes clinically negative OR lymph node involvement unknown 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 * Must have acceptable organ function for age * No uncontrolled infection * No other active malignancy * No other treated malignancy within the past 5 years * No hypersensitivity to study drugs * No Charcot-Marie-Tooth disease * No chickenpox PRIOR CONCURRENT THERAPY: Chemotherapy * No prior anticancer chemotherapy Endocrine therapy * Prior anticancer steroids allowed Radiotherapy * No prior radiotherapy Other * No concurrent pentostatin

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Japan Rhabdomyosarcoma Study Group: lead

Study Sites (51)

Anjo Kosei Hosptial

Anjo, Aichi-ken, 446-8602, Japan

RECRUITING

Aichi Medical University

Nagakuti, Aichi-ken, 480-1103, Japan

RECRUITING

National Hospital Orgnization Nagoya Medical Center

Nagoya, Aichi-ken, 460-0001, Japan

RECRUITING

Ehime Prefectural Central Hospital

Matsuyama, Ehime, 790-0024, Japan

RECRUITING

National Kyushu Cancer Center

Fukuoka, Fukuoka, 811-1395, Japan

RECRUITING

Kurume University School of Medicine

Kurume, Fukuoka, 830-0011, Japan

RECRUITING

Fukushima Medical University Hospital

Fukushima, Fukushima, 960-1295, Japan

RECRUITING

Gifu Municipal Hospital

Gifu, Gifu, 500-8513, Japan

RECRUITING

Gifu University Graduate School of Medicine

Gifu, Gifu, 500-8705, Japan

RECRUITING

Gunma Children's Medical Center

Seta-gun, Gunma, 377-8577, Japan

RECRUITING

Hiroshima University Hospital

Hiroshima, Hiroshima, 734-8551, Japan

RECRUITING

National Hospital Organization - Medical Center of Kure

Kure, Hiroshima, 737-0023, Japan

RECRUITING

Sapporo Medical University

Sapporo, Hokkaido, 060-8556, Japan

RECRUITING

Hokkaido University Graduate School of Medicine

Sapporo, Hokkaido, 060-8638, Japan

RECRUITING

Kobe City General Hospital

Kobe, Hyōgo, 650, Japan

RECRUITING

Ibaraki Children's Hospital

Mito, Ibaraki, 311-4145, Japan

RECRUITING

University of Tsukuba

Tsukuba, Ibaraki, 305-8575, Japan

RECRUITING

Ishikawa Prefectural Central Hospital

Kanazawa, Ishikawa-ken, 920-02, Japan

RECRUITING

Kanazawa Medical University

Kanazawa, Ishikawa-ken, 920-8641, Japan

RECRUITING

Kagoshima University

Kagoshima, Kagoshima-ken, 890-8520, Japan

RECRUITING

Kagoshima City Hospital

Kagoshima, Kagoshima-ken, 892-8580, Japan

RECRUITING

National Center for Child Health and Development

Tokyo, Kanagawa, 157-8535, Japan

RECRUITING

Showa University Fujigaoka Hospital

Yokohama, Kanagawa, 227-8502, Japan

RECRUITING

Yokohama City University

Yokohama, Kanagawa, 236-0004, Japan

RECRUITING

Kyoto Prefectural University of Medicine

Kyoto, Kyoto, 602-8566, Japan

RECRUITING

Kyoto University Hospital

Kyoto, Kyoto, 606-8507, Japan

RECRUITING

Miyazaki Medical College University of Miyazaki

Miyazaki-gun, Miyazaki, 889-1692, Japan

RECRUITING

Nagano Children's Hospital

Toyoshina-machi, Nagano, 399-8288, Japan

RECRUITING

Osaka Medical Center and Research Institute for Maternal and Child Health

Izumi, Osaka, 594-1101, Japan

RECRUITING

Osaka City University

Osaka, Osaka, 545-8586, Japan

RECRUITING

Osaka General Medical Center

Osaka, Osaka, 558-0056, Japan

RECRUITING

Osaka City General Hospital

Suita-shi, Osaka, 565-0871, Japan

RECRUITING

Osaka University Graduate School of Medicine

Suita-shi, Osaka, 565-0871, Japan

RECRUITING

Osaka Medical College

Takatsuki, Osaka, 569-8686, Japan

RECRUITING

Dokkyo University School of Medicine

Koshigaya, Saitama, 343-8555, Japan

RECRUITING

Saitama Children's Medical Center

Saitama, Saitama, 339-8551, Japan

RECRUITING

National Defense Medical College

Tokorozawa, Saitama, 359-8513, Japan

RECRUITING

Shiga University of Medical Science

Ōtsu, Shiga, 520-21, Japan

RECRUITING

Shimane Prefectural Central Hospital

Izumo, Shimane, 693-0068, Japan

RECRUITING

Shimane University Hospital

Izumo, Shimane, 693-8501, Japan

RECRUITING

Seirei Hamamatsu General Hospital

Hamamatsu, Shizuoka, 430-8558, Japan

RECRUITING

Tokyo Metropolitan Kiyose Children's Hospital

Kiyosei, Tokyo, 204-8567, Japan

RECRUITING

National Cancer Center Hospital

Tokyo, Tokyo, 104-0045, Japan

RECRUITING

St. Luke's International Hospital

Tokyo, Tokyo, 104, Japan

RECRUITING

Tokyo Medical and Dental University

Tokyo, Tokyo, 113-8510, Japan

RECRUITING

Toho University School of Medicine

Tokyo, Tokyo, 143-8541, Japan

RECRUITING

Keio University School of Medicine

Tokyo, Tokyo, 160-8582, Japan

RECRUITING

Nihon University Itabashi Hospital

Tokyo, Tokyo, 173, Japan

RECRUITING

Toyama University Hospital

Toyama, Toyama, 930-0194, Japan

RECRUITING

Yamagata University Hospital

Yamagata, Yamagata, 990-9585, Japan

RECRUITING

Hokkaido Medical Center for Child Health and Rehabilitation

Sapporo, 006-0041, Japan

RECRUITING

MeSH Terms

Conditions

Sarcoma

Interventions

Dactinomycin; Cyclophosphamide; Vincristine; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Indolizidines; Indolizines; Therapeutics

Study Officials

• Hajime Hosoi

  Kyoto Prefectural University of Medicine

  STUDY CHAIR

• Masa-aki Kumagai, MD

  National Center for Child Health and Development

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 25, 2005
• First Posted: October 27, 2005
• Study Start: May 1, 2004
• Primary Completion: April 1, 2011
• Last Updated: August 12, 2013

Record last verified: 2009-07

Locations

JP (51)