Phase II Trial of VAC2.2/VA Therapy for Low-Risk B Group Patients With Rhabdomyosarcoma
N/A
17 Years
Both
Sarcoma
Trial Information
Phase II Trial of VAC2.2/VA Therapy for Low-Risk B Group Patients With 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.
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 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Disease-free survival at 3 years after study registration
Safety Issue:
No
Principal Investigator
Hajime Hosoi
Investigator Role:
Study Chair
Investigator Affiliation:
Kyoto Prefectural University of Medicine
Authority:
Unspecified
Study ID:
CDR0000450162
NCT ID:
NCT00245089
Start Date:
May 2004
Completion Date:
Related Keywords:
- Sarcoma
- embryonal childhood rhabdomyosarcoma
- embryonal-botryoid childhood rhabdomyosarcoma
- previously untreated childhood rhabdomyosarcoma
- Rhabdomyosarcoma
- Rhabdomyosarcoma, Embryonal
- Sarcoma
Name | Location |
|---|
