NCT00276783Unknown2 期
A Phase II Trial of Alimta (Pemetrexed) in Patients With Recurrent Malignant Gliomas, Primary Central Nervous System Lymphoma, and Brain Metastases
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Progression free survival at 6 months and time to disease progression
研究概览
简要总结
RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating patients with recurrent malignant gliomas, primary CNS lymphoma, or brain metastases.
详细描述
OBJECTIVES:
Primary
- Determine the 6-month progression-free survival rate in patients with recurrent malignant gliomas treated with pemetrexed disodium.
- Determine the time to progression in patients with recurrent malignant gliomas, primary CNS lymphoma (PCNSL), or brain metastases treated with pemetrexed disodium.
Secondary
- Determine the radiographic response in patients with recurrent malignant gliomas, PCNSL, or brain metastases treated with pemetrexed disodium.
- Determine the time to response in patients treated with this drug.
- Determine the duration of response in patients treated with this drug.
- Determine the overall survival of patients treated with this drug.
- Collect safety data on patients with intracranial tumors treated with this drug.
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 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
Treatment Arm
Experimental
Pemetrexed 900 mg/m2 every 21 days until disease progression.
干预措施: pemetrexed (Drug)
结局指标
主要结局
Progression free survival at 6 months and time to disease progression
时间窗: After every 2 cycles of therapy (1 cycle = 3 weeks) until disease progression
次要结局
- Collect safety data(After every cycle of therapy (cycle = 3 weeks) until disease progression or death.)
- Radiographic response(After 6 months of treatment)
- Overall survival(After every cycle of treatment (1 cycle = 3 weeks) until death)
- Compare blood and tissue methylation patterns and correlate with response.(Blood and tissue from baseline, then additional blood every 6 weeks while on treatment)
研究者
研究点 (2)
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