Phase II Trial of Short VAC1.2 Therapy for Low-Risk A Group Patients With Rhabdomyosarcoma
N/A
17 Years
Both
Sarcoma
Trial Information
Phase II Trial of Short VAC1.2 Therapy for Low-Risk A Group Patients With 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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Disease-free survival as measured by Kaplan-Meier method 3 years after study entry
Safety Issue:
No
Principal Investigator
Hajime Hosoi
Investigator Role:
Study Chair
Investigator Affiliation:
Kyoto Prefectural University of Medicine
Authority:
Unspecified
Study ID:
CDR0000453316
NCT ID:
NCT00245141
Start Date:
May 2004
Completion Date:
Related Keywords:
- Sarcoma
- embryonal childhood rhabdomyosarcoma
- embryonal-botryoid childhood rhabdomyosarcoma
- previously untreated childhood rhabdomyosarcoma
- Rhabdomyosarcoma
- Rhabdomyosarcoma, Embryonal
- Sarcoma
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