A Phase I-II Study of Allogeneic CMV Specific Cytotoxic T Lymphocytes (CTL) for Patients With Refractory Glioblastoma Multiforme (GBM)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 25
- 主要终点
- To determine the incidence of tumor responses, as defined as stable disease, partial, or complete responses after the infusion of CMV CTL.
研究概览
简要总结
The primary purpose of this study is to determine the safety and efficacy of the infusion of partially matched, allogeneic, CMV specific cytotoxic T cells (CTL) for patients with GBM that have failed primary therapy.
详细描述
Tumor specimens of consenting patients will be tested by immunohistochemistry (IHC) for the presence of IE-1 and/or pp65. Subjects whose tumors test positive for either or both CMV antigens will be consented for the treatment phase which will include a regimen of fludarabine and cyclophosphamide daily for two days, cyclophosphamide only for a third day, followed by one day of rest prior to the day of CTL infusion.
This trial intended to be a Phase 1/2 trial, but it never progressed to Phase 2 before termination.
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
- 5 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •FOR SCREENING
- •Patients must have a histopathologic diagnosis of GBM.
- •Patients from 5 to 65 years of age with GBM.
- •FOR TREATMENT
- •GBM has progressed following primary therapy.
- •Tumor is CMV pp65 or IE1 positive by immunohistochemistry (IHC).
- •Subjects must have pulse oximetry > or = 94 % on no supplemental oxygen.
- •Creatinine clearance must be > 50 cc/min as estimated by patient's serum creatinine, weight, and age.
- •Bilirubin must be < 2.0 mg/dl and SGOT/SGPT < 2.5 X normal.
- •ECOG performance status must be < or = 2, and for patients <16 years of age, Lansky performance status must be > or = 70%.
排除标准
- •Pregnant females
- •Subjects who are moribund or who because of cardiac, pulmonary, renal, hepatic or neurologic dysfunction are not expected to survive one month following the T cell infusion
研究组 & 干预措施
GBM Treatment
干预措施: Fludarabine (Drug)
GBM Treatment
干预措施: Cyclophosphamide (Drug)
GBM Treatment
干预措施: CMV Specific Cytotoxic T Lymphocytes (CTL) (Biological)
结局指标
主要结局
To determine the incidence of tumor responses, as defined as stable disease, partial, or complete responses after the infusion of CMV CTL.
时间窗: 2 years
次要结局
- To determine the duration and magnitude of donor chimerism post infusion by micro chimerism assays.(2 years)
- To determine the incidence of increases in CMV pp65 or IE-1 T cells post infusion of allogeneic CMV CTL of GBM patients.(2 years)
- To determine safety of allogeneic CTL infusions in this patient population.(2 years)