Last updated on August 2013

Vincristine Dactinomycin and Cyclophosphamide With or Without Radiation Therapy 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 I or II (N0), defined by all of the following criteria:
    Favorable site, including orbit, head, and neck (excluding parameningeal
    ites), 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

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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