NCT00363012已完成不适用
Development of HER-2/Neu (HER2) ICD Memory Immunity After Vaccination With a Plasmid Encoding HER2 ICD in Patients With Advanced Stage HER2 Overexpressing Breast and Ovarian Cancers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 4
- 主要终点
- Immunologic memory response to HER-2/neu (HER2) intracellular domain protein
研究概览
简要总结
RATIONALE: Studying the immune response to a vaccine made from HER2/neu protein may help doctors plan better treatment for patients with breast cancer that overexpresses HER2.
PURPOSE: This clinical trial is studying the immune response in patients who have undergone vaccine therapy for stage III or stage IV breast cancer that overexpresses HER2.
详细描述
OBJECTIVES:
Primary
- Determine whether immunologic memory to the HER-2/neu (HER2) intracellular domain (ICD) protein has been generated by active immunization with a HER2 ICD plasmid-based vaccine by assessing the delayed-type hypersensitivity response to HER2 ICD peptides 6 months after vaccination in patients with HER2-overexpressing stage III or IV breast cancer.
Secondary
- Characterize the memory T-cell population and quantitate memory precursor frequency at 3, 6, and 12 months after active immunization using intracellular cytokine staining.
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
- Diagnostic
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Immunologic memory response to HER-2/neu (HER2) intracellular domain protein
时间窗: 6 months after active immunization
次要结局
- Characterization of memory T-cell population by intracellular cytokine staining(3, 6, and 12 months after active immunization)
- Quantitate memory precursor frequency by intracellular cytokine staining(3, 6, and 12 months after active immunization)
研究者
Mary (Nora) Disis
Principal Investigator
University of Washington
研究点 (4)
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