A Phase 2, Open-Label Study to Evaluate the Efficacy and Safety of Patient-Specific Immunotherapy, Recombinant Idiotype Conjugated to KLH (Id-KLH) and Administered With GM-CSF, in Patients With CNS Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Anti-idiotype (Id) and anti-keyhole limpet hemocyanin (KLH) immune response rate in the CSF
研究概览
简要总结
RATIONALE: Vaccines made from a person's cancer proteins may help the body build an effective immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving vaccine therapy together with GM-CSF may make a stronger immune response and kill more cancer cells.
PURPOSE: This phase II trial is studying the side effects and how well giving vaccine therapy together with GM-CSF works in treating patients with CNS lymphoma.
详细描述
OBJECTIVES:
Primary
- To determine the proportion of patients with CNS lymphoma who develop anti-idiotype (Id) and anti-keyhole limpet hemocyanin (KLH) humoral immune responses in the serum and/or CSF following patient-specific immunotherapy comprising recombinant tumor-derived immunoglobulin Id-KLH conjugate vaccine and sargramostim (GM-CSF).
- To assess the safety and tolerability of this regimen in these patients.
Secondary
- To evaluate the progression-free survival (PFS) of patients treated with this regimen.
- To determine the time to receipt of first subsequent anti-lymphoma therapy after initiating immunization with the Id-KLH conjugate vaccine.
- To assess the correlation of anti-Id immune response in the CSF and/or serum with PFS and overall survival.
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
methotrexate IV once every 2 weeks
干预措施: autologous immunoglobulin idiotype-KLH conjugate vaccine (Biological)
methotrexate IV once every 2 weeks
干预措施: sargramostim (Biological)
methotrexate IV once every 2 weeks
干预措施: methotrexate (Drug)
methotrexate IV once every 2 weeks
干预措施: thiotepa (Drug)
methotrexate IV once every 2 weeks
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Anti-idiotype (Id) and anti-keyhole limpet hemocyanin (KLH) immune response rate in the CSF
Safety and tolerability
次要结局
- Progression-free survival (PFS)
- Time to receipt of first subsequent anti-lymphoma therapy after initiating immunization with the Id-KLH conjugate vaccine
- Kinetics of humoral immune response development
- Correlation of anti-Id immune response in the CSF and/or serum with PFS and overall survival