Last updated on August 2013

Vincristine Dactinomycin and Cyclophosphamide in Treating Patients With Embryonal Rhabdomyosarcoma


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Sarcoma
  • Age: - 17 Years
  • Gender: Male or Female
  • Other:
    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

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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