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
- •DISEASE CHARACTERISTICS:
- •Cytologically confirmed relapsed CNS lymphoma
- •Arising from primary CNS lymphoma or systemic non-Hodgkin's lymphoma
- •Evidence of brain parenchymal involvement, cerebrospinal fluid (CSF) involvement, or ocular involvement after radiation treatment or intrathecal chemotherapy
- •Tumors must be CD20+ on pathologic analysis
- •Refractory or persistent disease allowed
- •No complete obstruction of the CSF pathway within the ventricular system unless alleviated by external beam radiotherapy or systemic chemotherapy
- •No obstructive hydrocephalus
- •PATIENT CHARACTERISTICS:
- •Karnofsky performance status > 50%
- •Must have an Ommaya reservoir
- •Granulocyte count > 1,500/mm^3
- •Platelet count > 50,000/mm^3
- •Anticipated survival ≥ 1 month
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Recovered from toxicity of prior therapy
- •Prior intrathecal methotrexate, cytarabine, or thiotepa for CNS lymphoma allowed
- •Concurrent systemic chemotherapy for treatment of disease outside meninges allowed except for high-dose methotrexate, high-dose cytarabine, high-dose thiotepa, or investigational agents
- •No history of whole-brain or craniospinal radiation < 1 week before study entry
- •No history of intrathecal chemotherapy < 1 week before study entry
- •No concurrent intrathecal chemotherapy
排除标准
- 未提供
研究组 & 干预措施
intrathecal rituximab
3 dose levels of intrathecal rituximab, 10mg, 25mg, 50mg
干预措施: rituximab (Biological)
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