A Phase I Study of Temozolomide and RAD001C in Patients With Malignant Glioblastoma Multiforme
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 18
- 主要终点
- Safety and tolerability of everolimus as measured by NCI CTCAE v3.0
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving temozolomide together with everolimus may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when given together with temozolomide in treating patients with newly diagnosed, recurrent, or progressive malignant glioblastoma multiforme.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose(s) and the recommended phase II dose(s) of everolimus when administered with standard-dose temozolomide in patients with newly diagnosed, recurrent, or progressive glioblastoma multiforme.
- Determine the toxicity of this regimen in these patients.
Secondary
- Determine the efficacy of this regimen in patients with measurable disease at baseline.
- Identify correlates of activity by molecular study of paraffin-embedded tumor samples from these patients.
- Determine the pharmacokinetics of this regimen in these patients.
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
结局指标
主要结局
Safety and tolerability of everolimus as measured by NCI CTCAE v3.0
时间窗: from the time of the first treatment
次要结局
- Correlation of clinical outcome with pretreatment tumor tissue molecular markers as measured by molecular studies of paraffin-embedded tumor samples(4 years)
- Pharmacokinetics of everolimus during course 1(during course 1)
- Response as measured by CT scan and/or brain MRI at baseline and after every other course and clinical neurologic assessment at baseline and after every course(after every other course)