Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Embryonal Rhabdomyosarcoma

Japan Rhabdomyosarcoma Study Group

Status and phase: Unknown; Phase 2

Conditions: Sarcoma

Treatments: Drug: vincristine sulfate; Biological: dactinomycin; Radiation: radiation therapy; Drug: cyclophosphamide

Study type: Interventional

Funder types: Other

Identifiers

NCT00245141

CDR0000453316 (Registry Identifier)

JRSG-UHA-PED03-01

Details and patient eligibility

About

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. Radiation therapy uses high energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving vincristine, dactinomycin, and cyclophosphamide together with or without radiation therapy works in treating patients with embryonal rhabdomyosarcoma.

Full description

OBJECTIVES:

• Determine the progression-free survival rate in patients with low-risk embryonal rhadomyosarcoma treated with a shortened treatment schedule of vincristine, dactinomycin, and cyclophosphamide with or without radiotherapy.

OUTLINE: Patients receive vincristine IV, dactinomycin IV, and cyclophosphamide IV. Patients may also undergo radiotherapy. Treatment repeats every 3 weeks for up to 8 courses (total of 24 weeks) in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.

Enrollment: 32 estimated patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 I or II (N0), defined by all of the following criteria:

    • Favorable site, including orbit, head, and neck (excluding parameningeal sites), 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