A Phase II Study Of Thalidomide And CPT-11 (IRINOTECAN) Following Radiotherapy For Glioblastoma Multiforme
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 4
- 主要终点
- Response
研究概览
简要总结
RATIONALE: Thalidomide may stop the growth of glioblastoma multiforme by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide with irinotecan may kill any tumor cells remaining after radiation therapy.
PURPOSE: Phase II trial to study the effectiveness of combining thalidomide with irinotecan in treating patients who have glioblastoma multiforme that has been treated with radiation therapy.
详细描述
OBJECTIVES:
- Determine the response rate of patients with glioblastoma multiforme treated with thalidomide and irinotecan after radiotherapy.
- Determine the preliminary efficacy of this regimen in these patients.
- Determine the disease-free survival and overall survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Assess the quality of life of patients treated with this regimen.
OUTLINE: Beginning 2-4 weeks after completion of radiotherapy, patients receive irinotecan IV over 90 minutes on day 1. Patients also receive oral thalidomide daily. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, 1 week after the first course, prior to all subsequent courses, and then after course 6.
Patients are followed for 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed glioblastoma multiforme (GBM)
- •Recurrent disease allowed
- •Evaluable disease on contrast-enhanced MRI
- •Prior external beam radiotherapy required
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •AST or ALT no greater than 5 times ULN
- •Creatinine no greater than 1.5 times ULN OR
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular:
- •No significant cardiac disease
- •No uncontrolled high blood pressure
- •No unstable angina
- •No congestive heart failure
- •No myocardial infarction within the past 3 months
- •No serious cardiac arrhythmias
- •Gastrointestinal:
- •Able to take oral medication
- •No gastrointestinal abnormalities
- •No requirement for IV alimentation
- •No active peptic ulcer disease
- •No active infection
- •No serious uncontrolled medical disorder
- •No dementia or significantly altered mental status that would preclude study
- •No known hypersensitivity to irinotecan or thalidomide
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use 2 forms of effective contraception, including 1 highly effective method, at least 1 month before, during, and for 1 month after study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior thalidomide
- •Chemotherapy:
- •No prior irinotecan
- •At least 4 weeks since other prior chemotherapy (and demonstrated evidence of disease progression or relapse)
- •Endocrine therapy:
- •Concurrent corticosteroids allowed if on a stable or decreasing dose for at least 1 week prior to study
- •No concurrent hormonal therapy for GBM
- •Radiotherapy:
- •See Disease Characteristics
- •No concurrent radiotherapy for GBM
- •No prior surgical procedures affecting absorption
- 另有 16 项未显示
排除标准
- 未提供
结局指标
主要结局
Response
时间窗: 2 years
To evaluate the response rate and hence preliminary efficacy of Irinotecan and Thalidomide following radiotherapy in the treatment of newly diagnosed or relapsed glioblastoma multiforme.
次要结局
- Toxicity / QOL / Survival(2 years)