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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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   (Child)
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
Anjo, Aichi, Japan, 446-8602
Aichi Medical University
Nagakuti, Aichi, Japan, 480-1103
National Hospital Orgnization Nagoya Medical Center
Nagoya, Aichi, Japan, 460-0001
Ehime Prefectural Central Hospital
Matsuyama-shi, Ehime, Japan, 790-0024
National Kyushu Cancer Center
Fukuoka-shi, Fukuoka, Japan, 811-1395
Kurume University School of Medicine
Kurume City, Fukuoka, Japan, 830-0011
Gifu Municipal Hospital
Gifu-shi, Gifu, Japan, 500-8513
Gunma Children's Medical Center
Seta-gun, Gunma, Japan, 377-8577
National Hospital Organization - Medical Center of Kure
Kure, Hiroshima, Japan, 737-0023
Sapporo Medical University
Sapporo, Hokkaido, Japan, 060-8556
Hokkaido University Graduate School of Medicine
Sapporo, Hokkaido, Japan, 060-8638
Kobe City General Hospital
Kobe, Hyogo, Japan, 650
Ibaraki Children's Hospital
Mito-shi, Ibaraki, Japan, 311-4145
University of Tsukuba
Tsukuba-city, Ibaraki, Japan, 305-8575
Ishikawa Prefectural Central Hospital
Kanazawa-shi, Ishikawa, Japan, 920-02
Kanazawa Medical University
Kanazawa, Ishikawa, Japan, 920-8641
Kagoshima City Hospital
Kagoshima City, Kagoshima, Japan, 892-8580
National Center for Child Health and Development
Tokyo, Kanagawa, Japan, 157-8535
Showa University Fujigaoka Hospital
Yokohama-shi, Kanagawa, Japan, 227-8502
Yokohama City University
Yokohama, Kanagawa, Japan, 236-0004
Miyazaki Medical College University of Miyazaki
Miyazaki-gun, Miyazaki, Japan, 889-1692
Nagano Children's Hospital
Toyoshina-machi, Nagano, Japan, 399-8288
Osaka Medical Center and Research Institute for Maternal and Child Health
Izumi, Osaka, Japan, 594-1101
Osaka City General Hospital
Suita-shi, Osaka, Japan, 565-0871
Osaka University Graduate School of Medicine
Suita-shi, Osaka, Japan, 565-0871
Osaka Medical College
Takatsuki City, Osaka, Japan, 569-8686
Dokkyo University School of Medicine
Koshigaya, Saitama, Japan, 343-8555
National Defense Medical College
Tokorozawa, Saitama, Japan, 359-8513
Shiga University of Medical Science
Otsu-shi, Shiga, Japan, 520-21
Shimane University Hospital
Izumo, Shimane, Japan, 693-8501
Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka, Japan, 430-8558
Fukushima Medical University Hospital
Fukushima, Japan, 960-1295
Gifu University Graduate School of Medicine
Gifu, Japan, 500-8705
Hiroshima University Hospital
Hiroshima, Japan, 734-8551
Kagoshima University
Kagoshima, Japan, 890-8520
Kyoto Prefectural University of Medicine
Kyoto, Japan, 602-8566
Kyoto University Hospital
Kyoto, Japan, 606-8507
Osaka City University
Osaka, Japan, 545-8586
Osaka General Medical Center
Osaka, Japan, 558-0056
Saitama Children's Medical Center
Saitama, Japan, 339-8551
Hokkaido Medical Center for Child Health and Rehabilitation
Sapporo, Japan, 006-0041
National Cancer Center Hospital
Tokyo, Japan, 104-0045
St. Luke's International Hospital
Tokyo, Japan, 104
Tokyo Medical and Dental University
Tokyo, Japan, 113-8510
Toho University School of Medicine
Tokyo, Japan, 143-8541
Keio University School of Medicine
Tokyo, Japan, 160-8582
Nihon University Itabashi Hospital
Tokyo, Japan, 173
Yamagata University Hospital
Yamagata, Japan, 990-9585
Sponsors and Collaborators
Japan Rhabdomyosarcoma Study Group
Investigators
Study Chair: Hajime Hosoi Kyoto Prefectural University of Medicine
OverallOfficial: Ryoji Hanada, MD Saitama Children's Medical Center
OverallOfficial: Keizo Horibe, MD, PhD National Hospital Orgnization Nagoya Medical Center
  More Information

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
Myosarcoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Cyclophosphamide
Vincristine
Dactinomycin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Protein Synthesis Inhibitors
Enzyme Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on December 06, 2016