NCT00576537已完成2 期
Phase ll Trial of Tumor Lysate-Pulsed Dendritic Cell Immunotherapy for Patients With Atypical or Malignant, Primary or Metastatic Brain Tumors of the Central Nervous System
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Evaluate the safety/toxicity of subcutaneous injections of autologous dendritic cells
研究概览
简要总结
This research is being determine whether vaccinations with your own immune cells called " dendritic cells " can activate your immune system to fight your brain tumor.
详细描述
To become eligible for therapy the following criteria must be fulfilled:
- No age or gender limit
- Patients with atypical malignant brain tumors.
- Must have a Karnofsky performance of at least 60%
- Hematologic studies and chemistry profiles will be within the parameters of the protocol
- Tumor specimen of adequate size to yield protein concentration, tumor lysate peptide must be generated in sufficient quantity and patient must have no prior sensitivity to the components of the dendritic cell vaccine.
- Patients are excluded if they have systemic disease, presence of acute infection, known history of autoimmune disorder and pregnancy.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No age or gender limit, though minimal weight limitations for apheresis is about 15 - 20 Kg.
- •Both male and female of childbearing age entering the protocol must use a medically accepted form of birth control during the study, will be required to have a negative pregnancy test for female.
- •patients with atypical malignant brain tumor will be eligible.
- •Patients must have a Karnofsky performance score of at least 60%
- •patients may be maintained on glucocorticoid therapy at the lowest possible dose.
- •Baseline hematologic studies and chemistry profiles must meet the criteria.
- •Tumor specimen of adequate size to yield protein concentration in sufficient quantity.
- •Tumor-lysate peptide must be generated in sufficient quantity to pulse the APC's for vaccination.
- •Patient must have no prior sensitivity to the components of the dendritic cell vaccine.
- •Patient must agree to consider an autopsy in the event of death in an attempt to learn more concerning the nature of this treatment and tumor biology.
- •Patient must be capable of signing IRB approved Research Consent and Release of medical Records form.
排除标准
- •Severe pulmonary, cardiac or other systemic disease associated with an unacceptable anesthetic or operative risk.
- •The presence of an acute infection requiring active treatment will be criteria for delay or exclusion.
- •Patients with a known history of an autoimmune disorder.
- •Inability to give informed consent.
- •Pregnancy.
研究组 & 干预措施
Dendritic Cell Immunotherapy
Experimental
Patients who consent to participate in the study and receive the Dendritic Cell vaccine manufactured from their own tumor cells.
干预措施: Dendritic Cell Immunotherapy (Biological)
结局指标
主要结局
Evaluate the safety/toxicity of subcutaneous injections of autologous dendritic cells
时间窗: One year
Cytotoxic T lymphocyte (CTL) precursor frequency
次要结局
未报告次要终点
研究者
John Yu
MD
Cedars-Sinai Medical Center
研究点 (2)
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