A Phase I/II Study of RAD001 and Radiation Therapy in Patients With Brain Metastasis From Non-small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
RATIONALE: 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving everolimus together with whole-brain radiation therapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus and to see how well it works when given together with whole-brain radiation therapy in treating patients with brain metastasis from non-small cell lung cancer.
详细描述
Phase I is intended to determine the maximum tolerated dose. Study drug will be administered orally, once a day, for 15 days, one day prior to initiation of WBRT at 5 or 10 mg/day during the phase I component. One of these doses will be selected as the maximum tolerable dose and will be selected for the phase II component.
OBJECTIVES:
Primary
- To determine the maximum-tolerated dose of everolimus when combined concurrently with whole-brain radiotherapy in patients with brain metastasis from stage IV non-small cell lung cancer. (Phase I)
- To evaluate the median survival of these patients treated with this regimen. (Phase II)
Secondary
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
Treatment
RAD001 + radiation therapy
干预措施: RAD001 (Drug)
Treatment
RAD001 + radiation therapy
干预措施: whole-brain radiation therapy (Radiation)
结局指标
主要结局
Maximum tolerated dose
时间窗: 4 week DLT period
Safety is measured by the rate of ≥ grade 3 hematological and non-hematologic study-related toxicities.
Median survival (phase II)
时间窗: Off-study date.
次要结局
- Intracranial response rate (phase II)(Off-treatment date.)
- Time to CNS (neurologic) progression (phase II)(Off-treatment date.)
- Time to systemic non-CNS progression (phase II)(Off-treatment date)
研究者
Vicki Keedy, MD
Medical Director, Vanderbilt-Ingram Cancer Center, Clinical Trials Shared Resource; Assistant Professor, Medical Oncologist
Vanderbilt-Ingram Cancer Center