Temozolomide For Patients With Cerebral Metastases Who Have Failed Radiation Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- To assess the rate of response/control of cerebral metastases from solid tumors to extended low dose, continuous oral temozolomide
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.
PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have advanced solid tumors that have spread to the brain.
详细描述
OBJECTIVES: I. Assess the response rate of patients with cerebral metastases who have failed or refused standard therapy when treated with temozolomide. II. Assess the safety and tolerability of this drug in these patients. III. Determine the quality of life of patients treated with this drug. IV. Determine the response rate of systemic disease outside the central nervous system in patients treated with this drug.
OUTLINE: Patients receive oral temozolomide daily for 6 weeks. Treatment repeats every 10 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Quality of life is assessed on day 1 of each 10-week course. Patients are followed for 30 days.
PROJECTED ACCRUAL: A total of 18-48 patients will be accrued for this study within 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
temozolomide
Administered in a fasting state, once a day for 6 weeks followed by 4 weeks of rest. Cycles may be repeated every 10 weeks until patients have evidence of progressive disease, intolerable toxicity or unwillingness to continue therapy. Daily dose: 75mg/m2.
干预措施: temozolomide (Drug)
结局指标
主要结局
To assess the rate of response/control of cerebral metastases from solid tumors to extended low dose, continuous oral temozolomide
时间窗: 2 years
次要结局
- to measure quality of life in patients with cerebral metastases treated with low dose, continuous temozolomide(2 years)
- To assess the safety and tolerability of low dose, continuous oral temozolomide in this patient population(2 years)
- To measure the rate of response of systemic disease outside the central nervous system to extended low dose continuous oral temozolomide(2 years)