NCT01018836终止1 期
A Phase I Trial of Riluzole in Combination With Radiation Therapy in Patients Undergoing Whole Brain Radiation Therapy for Brain Metastasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose of riluzole
研究概览
简要总结
RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs, such as riluzole, may make tumor cells more sensitive to radiation therapy. Giving riluzole together with whole-brain radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of riluzole when given together with whole-brain radiation therapy in treating patients with brain metastases.
详细描述
OBJECTIVES:
Primary
- To determine the maximum tolerated dose of riluzole that can be administered concurrently with standard whole-brain radiotherapy (WBRT) in patients with multiple brain metastases.
Secondary
- To determine the long-term toxicity of riluzole when administered with WBRT.
- To assess neurocognitive function before and after treatment with riluzole and WBRT.
- To determine the MRI response of brain metastasis after treatment with riluzole and WBRT.
- To compare survival of patients treated with riluzole and WBRT to published historical data for patients with brain metastases.
- To evaluate the response of brain metastasis to riluzole and WBRT as a function of the expression of glutamate receptors on the primary tumor specimen.
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
Riluzole; Radiation Therapy
Experimental
干预措施: riluzole (Drug)
Riluzole; Radiation Therapy
Experimental
干预措施: whole-brain radiation therapy (Radiation)
结局指标
主要结局
Maximum tolerated dose of riluzole
时间窗: 2.5 years
次要结局
- Long-term toxicity of riluzole(.25 years)
- Neurocognitive function before and after treatment(2.5 years)
- MRI response of brain metastasis after treatment(2.5 years)
- Survival(2.5 years)
- Response of brain metastasis to treatment as a function of the expression of glutamate receptors(2.5 years)
研究者
研究点 (1)
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