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

Japan Rhabdomyosarcoma Study Group

Status and phase: Unknown; Phase 2

Conditions: Sarcoma

Treatments: Drug: vincristine sulfate; Drug: cyclophosphamide; Biological: dactinomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT00245089

CDR0000450162 (Registry Identifier)

JRSG-UHA-PED03-02

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. 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.

Full 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.

Enrollment: 41 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 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