Phase I/II Study of High Dose Irinotecan (Camptosar, CPT-11) in Patients With Recurrent Unresectable Malignant Glioma on Steroids/Anti-epileptics
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The purpose of this study is to compare the response to treatment and side effects associated with high dose irinotecan in patients with recurrent brain tumors.
研究概览
简要总结
The purpose of this study is to compare the response to treatment and side effects associated with high dose irinotecan in patients with recurrent brain tumors.
详细描述
This is a phase I/II study of high dose irinotecan in patients with recurrent unresectable malignant glioma on steroids/anti-epileptics. The purpose is to compare the response to treatment and side effects associated with high dose irinotecan in patients with recurrent brain tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •recurrent, unresectable primary CNS neoplasm per MRI
- •ECOG status of 2 or less
- •no prior therapy with camptothecans
- •on an enzyme-inducing antiepileptic
排除标准
- 未提供
研究组 & 干预措施
Cohort #1
Cohort #1--Irinotecan 750 mg/m2 IV over 90 minutes every (Q) 3 weeks x 15 patients.
Additional increments of 50 mg/m2 for subsequent cohorts until MTD is reached.
干预措施: Irinotecan (Camptosar, CPT-11) (Drug)
Cohort #2
Cohort #2--Irinotecan 500 mg/m2 IV over 90 minutes Q 2 weeks x 3 patients.
Additional increments of 50 mg/m2 for subsequent cohorts until MTD is reached.
干预措施: Irinotecan (Camptosar, CPT-11) (Drug)
Cohort #3
Cohort #3--Irinotecan 600 mg/m2 IV over 90 minutes Q 2 weeks x 3 patients.
Additional increments of 50 mg/m2 for subsequent cohorts until MTD is reached.
干预措施: Irinotecan (Camptosar, CPT-11) (Drug)
结局指标
主要结局
The purpose of this study is to compare the response to treatment and side effects associated with high dose irinotecan in patients with recurrent brain tumors.
时间窗: 2008
次要结局
未报告次要终点