A Phase II Trial of Preradiation Multiagent Chemotherapy for Adults With "Poor Risk" Medulloblastoma, PNET, and Disseminated Ependymoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 14
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 drug and combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy in treating adult patients with brain cancer.
详细描述
OBJECTIVES:
- Determine the complete and partial response rate of patients with adult medulloblastoma, primitive neuroectodermal tumor, or disseminated ependymoma treated with preradiation combination chemotherapy.
- Determine the progression free survival and overall survival of these adult patients treated with combination chemotherapy followed by craniospinal radiation.
- Determine the toxic effects associated with this treatment in these patients.
OUTLINE: Patients receive cisplatin IV over 6 hours, etoposide IV, and vincristine IV over 1-2 minutes on day 1; etoposide IV and cyclophosphamide IV over 1-2 hours on days 2-3; filgrastim (G-CSF) subcutaneously (SC) on days 4-13; and vincristine IV over 1-2 minutes on day 15. Treatment repeats every 42 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Within 4-6 weeks after the last chemotherapy course, patients undergo radiotherapy 5 days a week for 6 to 7 weeks.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5-10 years.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed central nervous system cancer including:
- •Medulloblastoma with either local residual disease of greater than 1 cm^2 on MRI following resection or evidence of metastases (M1-4)
- •Other primitive neuroectodermal tumors
- •Ependymoma with evidence of subarachnoid metastases
- •Must have less than 1 cm of midline shift or no acute elevated intercranial pressure
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC greater than 4,000/mm^3
- •Platelet count greater than 125,000/mm^3
- •Hemoglobin greater than 10 g/dL
- •No preexisting hematologic condition that would increase toxicity or limit ability to comply with evaluations and follow-up
- •Bilirubin less than 2 times upper limit of normal (ULN)
- •SGOT less than 2 times ULN
- •Alkaline phosphatase less than 2 times ULN
- •No preexisting hepatic condition that would increase toxicity or limit ability to comply with evaluations and follow-up
- •Creatinine greater than 70 mL/min
- •No preexisting renal condition that would increase toxicity or limit ability to comply with evaluations and follow-up
- •No history of significant pulmonary disease or, if there is preexisting pulmonary disease, then DLCO greater than 60% of predicted
- •No preexisting pulmonary condition that would increase toxicity or limit ability to comply with evaluations and follow-up
- •No preexisting psychiatric condition that would increase toxicity or limit ability to comply with evaluations and follow-up
- •No prior or concurrent malignancies within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior chemotherapy
- •Endocrine therapy:
- •No increasing doses of steroids for intracranial disease within 3 days of registration
- •Radiotherapy:
- •No prior radiotherapy
- •10-28 days since prior surgical resection OR
- •At least 5 days since prior biopsy
排除标准
- 未提供