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Vincristine, Dactinomycin, and Cyclophosphamide in Treating Patients With Embryonal Rhabdomyosarcoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00245089
First received: October 25, 2005
Last updated: August 9, 2013
Last verified: July 2009
  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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Disease-free survival at 3 years after study registration [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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)
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.

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00245089

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 City General Hospital Recruiting
Suita-shi, Osaka, Japan, 565-0871
Contact: Junichi Hara    81-6-6929-1221      
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 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 Prefectural University of Medicine Recruiting
Kyoto, Japan, 602-8566
Contact: Hajime Hosoi    81-75-251-5571    hhosoi@koto.kpu-m.ac.jp   
Kyoto University Hospital Recruiting
Kyoto, Japan, 606-8507
Contact: Kenichiro Watanabe, MD    81-75-751-3297    wataken@kuhp.kyoto-u.ac.jp   
Osaka City University Recruiting
Osaka, Japan, 545-8586
Contact: Kazumi Yamato    81-6-6645-3175      
Osaka General Medical Center Recruiting
Osaka, Japan, 558-0056
Contact: Keiko Yumura-Yagi, MD    81-6-6692-1201      
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      
Nihon University Itabashi Hospital Recruiting
Tokyo, Japan, 173
Contact: Hideo Mugishima, MD    81-3-3972-8111 ext. 2700      
National Cancer Center Hospital Recruiting
Tokyo, Japan, 104-0045
Contact: Atsushi Makimoto    81-3-3542-2511      
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      
Keio University School of Medicine Recruiting
Tokyo, Japan, 160-8582
Contact: Yasuhide Morikawa, MD    81-3-5363-2593    ymorikaw@sc.itc.keio.ac.jp   
Yamagata University Hospital Recruiting
Yamagata, Japan, 990-9585
Contact: Mitsui Tetsuo, MD, DMedSci    81-23-628-5329    tmitsui@med.id.yamagata-u.ac.jp   
Sponsors and Collaborators
Japan Rhabdomyosarcoma Study Group
Investigators
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: JRSG-UHA-PED03-02, CDR0000450162
Study First Received: October 25, 2005
Last Updated: August 9, 2013
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
Myosarcoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Neoplasms, Muscle Tissue
Sarcoma
Cyclophosphamide
Dactinomycin
Vincristine
Alkylating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Protein Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014