A Study to Assess HER2-Specific T Cell Responses in Patients Receiving Trastuzumab for Solid Tumor Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- T-cell activation in blood samples
研究概览
简要总结
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment. It may also help the study of cancer in the future.
PURPOSE: This laboratory study is looking at blood samples from patients receiving trastuzumab and/or chemotherapy for HER2-positive solid tumors to assess T-cell response.
详细描述
OBJECTIVES:
- Assess T-cell activation in blood samples of patients receiving trastuzumab (Herceptin®) and/or chemotherapy for HER2-positive solid tumors.
OUTLINE: Blood samples are collected from patients at baseline and on days 21, 42, and 84 of trastuzumab (Herceptin®)/chemotherapy. Patients may be contacted 3-6 months after completion of trastuzumab/chemotherapy to donate another blood specimen.
Blood samples are examined for T-cell proliferation and intracellular cytokine production. CD8 T-cell response, HER2/neu-specific antibody titers, and skin hypersensitivity test responses are also measured.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
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
- •DISEASE CHARACTERISTICS:
- •Diagnosis of solid epithelial tumor, including, but not limited to, the following:
- •Breast cancer
- •Ovarian cancer
- •Lung cancer
- •Uterine cancer
- •Prostate cancer
- •HER2/neu-positive disease by immunohistochemistry or fluorescent in situ hybridization
- •Must be receiving trastuzumab (Herceptin®) and/or chemotherapy (e.g., paclitaxel, docetaxel, fluorouracil, or estramustine)
- •PATIENT CHARACTERISTICS:
- •Absolute neutrophil count > 1,000/mm^3
- •Absolute lymphocyte count > 400/mm^3
- •Platelet count > 90,000/mm^3
- •Hemoglobin > 8 g/dL
- •PRIOR CONCURRENT THERAPY:
- •No other chemotherapy within the past 4 weeks
排除标准
- 未提供
研究组 & 干预措施
trastuzumab
blood sample collected on different days from patients receiving trastuzumab
干预措施: trastuzumab (Biological)
结局指标
主要结局
T-cell activation in blood samples
时间窗: 3 months
次要结局
未报告次要终点