Zenapax®-Activated Peptide ImmunoTherapy [ZAP IT]
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Functional suppressive capacity of CD4+CD25+CD127- T-regulatory cells
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Vaccines may help the body build an effective immune response to kill tumor cells. Monoclonal antibodies, such as basiliximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving chemotherapy, radiation therapy, and vaccine therapy together with basiliximab is a more effective treatment for glioblastoma multiforme than chemotherapy, radiation therapy, and vaccine therapy alone.
PURPOSE: This randomized phase I trial is studying the side effects and best way to give chemotherapy and radiation therapy followed by vaccine therapy with basiliximab in treating patients with glioblastoma multiforme that has been removed by surgery.
详细描述
OBJECTIVES:
Primary
- To determine if basiliximab inhibits the functional and numeric recovery of T-regulatory cells (Tregs) after therapeutic temozolomide (TMZ)-induced lymphopenia in the context of vaccinating adult patients with newly diagnosed glioblastoma multiforme (GBM) using PEPvIII-keyhole limpet hemocyanin (KLH).
Secondary
- To evaluate the safety of basiliximab in the context of vaccinating adult patients with newly diagnosed GBM using PEP-3-KLH conjugate vaccine during recovery from therapeutic TMZ-induced lymphopenia.
- To determine if basiliximab enhances the magnitude or character of PEPvIII-KLH-induced cellular or humoral immune responses, inhibits or enhances activation-induced cell death, or induces immunologic or clinical evidence of autoimmunity.
- To determine if basiliximab enhances the magnitude or character of PEPvIII-KLH-induced cellular or humoral immune responses, inhibits or enhances activation-induced cell death, or induces immunologic or clinical evidence of autoimmunity.
- To determine if basiliximab alters the phenotype (CD56-expression), cytokine secretion profile, or cytotoxicity of CD3-negative CD56-positive natural killer cells.
- To determine if basiliximab, in addition to vaccination, extend progression-free survival compared to historical cohorts.
- To characterize immunologic cell infiltrate in recurrent tumors and seek evidence of antigen escape outgrowth.
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
- 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
Arm I
Temozolomide, PEP-3-KLH conjugate vaccine, and daclizumab
干预措施: PEP-3-KLH conjugate vaccine (Biological)
Arm I
Temozolomide, PEP-3-KLH conjugate vaccine, and daclizumab
干预措施: daclizumab (Biological)
Arm I
Temozolomide, PEP-3-KLH conjugate vaccine, and daclizumab
干预措施: temozolomide (Drug)
Arm II
Temozolomide, PEP-3-KLH conjugate vaccine, and normal saline
干预措施: PEP-3-KLH conjugate vaccine (Biological)
Arm II
Temozolomide, PEP-3-KLH conjugate vaccine, and normal saline
干预措施: temozolomide (Drug)
Arm II
Temozolomide, PEP-3-KLH conjugate vaccine, and normal saline
干预措施: placebo (Other)
Basiliximab
Patients will receive basiliximab 20 mg IV with vaccine # 1 only and continue with PEP-3-KLH, temozolomide.
干预措施: PEP-3-KLH (Biological)
结局指标
主要结局
Functional suppressive capacity of CD4+CD25+CD127- T-regulatory cells
时间窗: 26 months
Comparison of proliferative T-cell response to phytohemagglutinin (PHA) among treatment groups (with versus without daclizumab/basiliximab)
时间窗: 26 months
次要结局
未报告次要终点
研究者
John Sampson
Professor of Neurosurgery
Duke University