A Modified Phase I/II Trial Of Rapamycin In Patients With Glioblastoma Multiforme
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Efficacy in terms of progression-free survival at 6 months and objective response (phase II)
研究概览
简要总结
RATIONALE: Chemotherapy drugs such as sirolimus use different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed during surgery.
PURPOSE: Phase I/II trial to study the effectiveness of sirolimus in treating patients who have glioblastoma multiforme that did not respond to previous radiation therapy.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of sirolimus in patients with glioblastoma multiforme.
- Determine the safety profile of this drug in these patients.
- Determine the efficacy of this drug, in terms of 6-month progression-free survival and objective response, in these patients.
OUTLINE: This is a dose-escalation study.
- Phase I: Patients receive oral sirolimus for 5-7 days before surgery. Patients then undergo surgical resection. Patients resume oral sirolimus once daily after full recovery from surgery. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of sirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
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 120 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
Phase 1
See intervention description.
干预措施: Rapamycin (Drug)
Phase 1
See intervention description.
干预措施: Surgery (Procedure)
Phase 1
See intervention description.
干预措施: Supportive Care (Procedure)
Phase 2
See intervention description.
干预措施: Rapamycin (Drug)
Phase 2
See intervention description.
干预措施: Surgery (Procedure)
Phase 2
See intervention description.
干预措施: Supportive Care (Procedure)
结局指标
主要结局
Efficacy in terms of progression-free survival at 6 months and objective response (phase II)
时间窗: 6 months after last subject finishes trial
Maximum tolerated dose (for phase 1)
时间窗: end of phase 1
次要结局
- Safety Profile (phase I)(end of phase I)
- Further evaluate safety profile(end of phase II)