A Phase II "Up-Front Window Study" of Irinotecan (CPT-11) Followed by Multimodal, Multiagent, Therapy for Selected Children and Adolescents With Newly Diagnosed Stage 4/Clinical Group IV Rhabdomyosarcoma: An IRS-V Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 237
- 主要终点
- Event Free Survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy combined with radiation therapy in treating patients who have metastatic rhabdomyosarcoma or sarcoma.
详细描述
OBJECTIVES:
- Determine the response rate of patients with newly diagnosed high-risk metastatic stage IV/clinical group IV rhabdomyosarcoma treated with upfront window therapy comprising irinotecan and vincristine.
- Determine the toxic effects of this regimen in these patients.
- Determine the toxic effects of this regimen when given in alternating courses with vincristine, dactinomycin, and cyclophosphamide (VAC) as continuation therapy in patients with partial or complete response.
- Determine the overall and failure-free survival of patients treated with irinotecan and vincristine followed by VAC alone or VAC alternating with vincristine and irinotecan plus radiotherapy.
- Determine the pharmacokinetics of irinotecan and vincristine in these patients.
OUTLINE:
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Upfront window therapy: Patients receive vincristine IV on days 1 and 8 and irinotecan IV over 60 minutes on days 1-5 and 8-12. Treatment repeats every 21 days for a total of 2 courses. Patients experiencing partial or complete response proceed to regimen A. Patients experiencing stable or progressive disease proceed to regimen B.
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Regimen A: Patients receive vincristine IV over 1 minute weekly on weeks 6-13, 15-19, 23-27, 29, 32-35, 38-39, and 41; dactinomycin IV over 1 minute weekly on weeks 6, 12, 23, 29, 35, and 41; and cyclophosphamide IV over 30-60 minutes weekly on weeks 6, 12, 16, 19, 23, 29, 35, and 41. Patients also receive irinotecan IV over 1 hour daily, 5 days a week, on weeks 9, 10, 26, 27, 32, 33, 38, and 39 and undergo radiotherapy daily, 5 days a week, on weeks 15-22.
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Regimen B: Patients receive vincristine as in regimen A; dactinomycin IV over 1 minute weekly on weeks 6, 9, 12, 23, 26, 29, 32, 35, 38, and 41 and cyclophosphamide IV over 30-60 minutes weekly on weeks 6, 9, 12, 16, 19, 23, 26, 29, 32, 35, 38, and 41. Patients receive radiotherapy as in regimen A.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 49 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed metastatic stage IV/clinical group IV rhabdomyosarcoma, undifferentiated sarcoma, or ectomesenchymoma
- •No metastatic embryonal tumors in patients under 10 years of age, regardless of primary site
- •Metastatic tumors of parameningeal sites eligible
- •Bidimensionally measurable disease
- •No positive cerebrospinal fluid cytology or multiple intracranial metastases
- •Patients presenting with the following are only eligible for continuation therapy and may not receive irinotecan/vincristine upfront window therapy:
- •Evidence of base of skull erosion or skull metastatic disease that displaces or indents the dura, compresses the brain parenchyma, or causes evidence of cranial nerve palsy
- •Tumor that touches or displaces the spinal cord
- •Evidence of intracranial primary tumor extension
- •Tumors that could cause potentially life-threatening complications (e.g., renal, airway) with progression due to location and/or growth rate
- •Requires emergency radiotherapy
- •Lab values are consistent with disseminated intravascular coagulation
- •PATIENT CHARACTERISTICS:
- •Under 50 (alveolar rhabdomyosarcoma, undifferentiated sarcoma, and ectomesenchymoma patients)
- •10 to 49 (embryonal histology patients)
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •See Disease Characteristics
- •Absolute neutrophil count greater than 1,000/mm^3*
- •Platelet count greater than 150,000/mm^3* NOTE: *Unless there is tumor involvement of bone marrow
- •Bilirubin less than 1.5 mg/dL
- •PT, PTT, and fibrinogen less than 1.5 times upper limit of normal
- •Creatinine less than 1.2 mg/dL
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior chemotherapy
- •Endocrine therapy:
- •Prior steroids allowed
- •Radiotherapy:
- •See Disease Characteristics
- •No prior radiotherapy
- •No more than 42 days since prior initial surgical procedure, including biopsy for diagnosis
排除标准
- 未提供
结局指标
主要结局
Event Free Survival
次要结局
未报告次要终点