NCT00639639已完成1 期
Anti-Tumor Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed Glioblastoma Multiforme During Recovery From Therapeutic Temozolomide-induced Lymphopenia
Gary Archer Ph.D.2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2006年2月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Feasibility and safety of vaccination with cytomegalovirus pp65-LAMP mRNA-loaded dendritic cells (DCs) with or without autologous lymphocyte transfer
研究概览
简要总结
RATIONALE: Vaccines may help the body build an effective immune response to kill cancer cells. Radiation therapy uses high-energy x-rays to kill cancer cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving vaccine therapy together with radiation therapy and chemotherapy may kill more cancer cells.
PURPOSE: This randomized phase I/II trial is studying how well vaccine therapy works in treating patients with newly diagnosed glioblastoma multiforme recovering from lymphopenia caused by temozolomide.
详细描述
OBJECTIVES:
Primary
- To evaluate the feasibility and safety of vaccination with cytomegalovirus (CMV) pp65-lysosomal-associated membrane protein (LAMP) mRNA-loaded dendritic cells (DCs) during recovery from therapeutic temozolomide-induced lymphopenia with or without autologous lymphocyte transfer (ALT) in patients with newly diagnosed glioblastoma multiforme and who are seropositive or seronegative for CMV.
Secondary
- To assess humoral and cellular immune responses in these patients to CMV pp65-LAMP mRNA-loaded dendritic cell (CMV-DC) vaccine and to compare the impact of ALT and CMV seropositivity on these parameters.
- To determine if vaccination with or without ALT extends total time to progression or overall survival of these patients when compared to a recent historical cohort.
- To assess the differential ability of indium In^111-labeled DCs to track to the inguinal lymph nodes under different skin preparative conditions.
- To assess the differential ability of ^111In-labeled DCs to track to lymph nodes on the tumor-bearing and non-tumor-bearing side of the cervical lymph nodes.
- To characterize immunologic cell infiltrate in recurrent tumors and seek evidence of antigen escape in recurrent or progressive tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years of age.
- •World Health Organization (WHO) Grade IV glioma with definitive resection prior to leukapheresis with residual radiographic contrast enhancement on most recent CT or MRI of <1 cm in maximal diameter in any axial plane.
- •Karnofsky Performance Status (KPS ) of > 80% and a Curran Group status of I-IV.
排除标准
- •Radiographic or cytologic evidence of leptomeningeal or multicentric disease at the time of enrollment.
- •Prior conventional anti-tumor therapy other than steroids, RT, Avastin or TMZ.
- •Pregnant or need to breast feed during the study period (Negative Beta-Human Chorionic Gonadotrophin [HCG] test required).
- •Requirement for continuous corticosteroids above physiologic levels at time of first vaccination.
- •Active infection requiring treatment or an unexplained febrile (> 101.5o F) illness.
- •Known immunosuppressive disease or human immunodeficiency virus infection.
- •Patients with unstable or severe intercurrent medical conditions such as severe heart or lung disease.
- •Allergic or unable to tolerate TMZ for reasons other than lymphopenia.
- •Patients with previous inguinal lymph node dissection.
结局指标
主要结局
Feasibility and safety of vaccination with cytomegalovirus pp65-LAMP mRNA-loaded dendritic cells (DCs) with or without autologous lymphocyte transfer
时间窗: 26 months
次要结局
- Evidence of antigen-escape outgrowth in recurrent or progressive tumors(At progression)
- Differential ability of indium In-111-labeled DCs to track to lymph nodes on the tumor bearing and non-tumor bearing side of the cervical lymph nodes(At vaccine # 4)
- Time to progression(From time of surgery/diagnosis to date of progression.)
- Differential ability of indium In-111-labeled DCs to track to the inguinal lymph nodes under different skin preparative conditions(At vaccine # 4)
- Humoral and cellular immune responses(26 months)
- Immunologic cell infiltrate in recurrent tumors(At progression)
研究者
Gary Archer Ph.D.
Assistant Professor Neurosurgery
Duke University
研究点 (2)
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