Trial | NCT00245089  Report issue

Title

Vincristine, Dactinomycin, and Cyclophosphamide in Treating Patients With Embryonal Rhabdomyosarcoma
Phase II Trial of VAC2.2/VA Therapy for Low-Risk B Group Patients With Rhabdomyosarcoma

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    41
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.
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.
Study Started
May 31
2004
Primary Completion
Apr 30
2011
Anticipated
Last Update
Aug 12
2013
Estimate

Biological dactinomycin

Drug cyclophosphamide

Drug vincristine sulfate

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
No Results Posted