Status:
UNKNOWN
Vincristine, Dactinomycin, and Cyclophosphamide in Treating Patients With Embryonal Rhabdomyosarcoma
Lead Sponsor:
Japan Rhabdomyosarcoma Study Group
Conditions:
Sarcoma
Eligibility:
All Genders
Up to 17 years
Phase:
PHASE2
Brief Summary
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 the...
Detailed Description
OBJECTIVES: * Determine the progression-free survival rate in patients with low-risk embryonal rhabdomyosarcoma treated with intensive chemotherapy comprising vincristine, dactinomycin, and cyclophos...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00245089
Start Date
May 1 2004
Last Update
August 12 2013
Active Locations (48)
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1
Anjo Kosei Hosptial
Anjo, Aichi-ken, Japan, 446-8602
2
Aichi Medical University
Nagakuti, Aichi-ken, Japan, 480-1103
3
National Hospital Orgnization Nagoya Medical Center
Nagoya, Aichi-ken, Japan, 460-0001
4
Ehime Prefectural Central Hospital
Matsuyama, Ehime, Japan, 790-0024