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Status:

UNKNOWN

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

Lead Sponsor:

Japan Rhabdomyosarcoma Study Group

Conditions:

Sarcoma

Eligibility:

All Genders

Up to 17 years

Phase:

PHASE2

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 the...

Detailed Description

OBJECTIVES: * Determine the progression-free survival rate in patients with low-risk embryonal rhabdomyosarcoma treated with intensive chemotherapy comprising vincristine, dactinomycin, and cyclophos...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    May 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    41 Patients enrolled

    Trial Details

    Trial ID

    NCT00245089

    Start Date

    May 1 2004

    Last Update

    August 12 2013

    Active Locations (48)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 12 (48 locations)

    1

    Anjo Kosei Hosptial

    Anjo, Aichi-ken, Japan, 446-8602

    2

    Aichi Medical University

    Nagakuti, Aichi-ken, Japan, 480-1103

    3

    National Hospital Orgnization Nagoya Medical Center

    Nagoya, Aichi-ken, Japan, 460-0001

    4

    Ehime Prefectural Central Hospital

    Matsuyama, Ehime, Japan, 790-0024