NCT00029523已完成4 期
A Randomized Clinical Study to Determine the Patient Benefit and Safety of Depocyt (Cytarabine Liposome Injection) for the Treatment of Neoplastic Meningitis
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 46
- 主要终点
- Progression-free survival, defined as the time to neurological progression or death
研究概览
简要总结
The purpose of this study is to find out how well an experimental drug called DepoCyt works for neoplastic meningitis (cancer that has spread to the tissues around the brain and spinal cord). DepoCyt is a new slow-release form of the cancer drug called ara-C (cytarabine). Cytarabine has been used for many years to treat cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
结局指标
主要结局
Progression-free survival, defined as the time to neurological progression or death
次要结局
- Time to neurological progression;
- Survival (all-cause and meningeal disease-specific)
- Frequency of improvement in pre-existing meningeal-disease related neurological deficits
- Karnofsky Performance Scores (KPS)
- Quality of life
- Cytological response rate
- Overall safety profile
研究者
研究点 (46)
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