Phase I Study of Intrathecal Rituximab in Patients With Recurrent CNS Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- Cerebrospinal Fluid (CSF) concentration of Rituximab
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving rituximab intrathecally may be an effective treatment for recurrent CNS lymphoma.
PURPOSE: This phase I trial is studying the side effects and best dose of intrathecal rituximab in treating patients with recurrent CNS lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine the safety and pharmacokinetics of intrathecal rituximab in patients with recurrent CNS lymphoma arising from CD20+ B-cell non-Hodgkin's lymphoma.
Secondary
- Determine the efficacy of intrathecal rituximab.
- Determine the molecular pathogenesis of lymphomatous meningitis.
- Determine the molecular basis for response or lack of response to rituximab.
- Identify molecular markers specific for lymphomatous meningitis that will be useful for prognostic evaluation of peripheral lymphomas.
- Determine the quality of life of patients treated with intrathecal rituximab.
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
- 17 Years 至 —（Child, 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
Cerebrospinal Fluid (CSF) concentration of Rituximab
时间窗: during 5 weeks of study treatment
Adverse events as a measure of safety of intrathecal administration of Rituximab
时间窗: up to 5 years after completion of 5 week study treatment
Serum concentration of Rituximab
时间窗: during 5 weeks of study treatment
次要结局
未报告次要终点