Trial | NCT00245141  Report issue

Title

Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Embryonal Rhabdomyosarcoma
Phase II Trial of Short VAC1.2 Therapy for Low-Risk A Group Patients With Rhabdomyosarcoma

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    32
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.
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.
Study Started
May 31
2004
Primary Completion
Apr 30
2011
Anticipated
Last Update
Aug 12
2013
Estimate

Biological dactinomycin

Drug cyclophosphamide

Drug vincristine sulfate

Radiation radiation therapy

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
No Results Posted