Phase II Trial of Salvage Chemotherapy With Temozolomide in Combination With Topotecan for Primary CNS Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Rate of complete radiologic response (CR)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as temozolomide and topotecan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving temozolomide together with topotecan works in treating patients with primary CNS lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine the complete radiologic response rate in patients with primary CNS lymphoma treated with salvage chemotherapy comprising temozolomide and topotecan.
Secondary
- Determine the median and failure-free survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine the overall response rate in patients treated with this regimen.
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 75 Years（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, Topotecan
Patient will take on days 1-5 of a 28-days schedule. Take Topotecan on days 2-6 of the 28 day schedule
干预措施: temozolomide (Drug)
Temozolomide, Topotecan
Patient will take on days 1-5 of a 28-days schedule. Take Topotecan on days 2-6 of the 28 day schedule
干预措施: topotecan hydrochloride (Drug)
结局指标
主要结局
Rate of complete radiologic response (CR)
时间窗: July 2006
次要结局
- Failure-free survival(July 2006)
- Toxicity(July 2006)
- Median overall survival(July 2006)
- Overall response rate (CR and partial response)(July 2006)