Phase II Study to Evaluate the Development of HER2/Neu (HER2)-Specific Memory T Cells After HER2 Peptide-based Vaccination in Patients With Advanced Stage Her2+ Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Quantification and characterization of HER2-specific TCM and TEM subsets in PBMC
研究概览
简要总结
This phase II trial studies how well vaccine therapy works in treating patients with stage IV hormone receptor positive breast cancer. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells.
详细描述
PRIMARY OBJECTIVES:
I. To quantify and characterize human epidermal growth factor receptor 2 (HER2)-specific central memory T cell (TCM) and effector memory T cell (TEM) subsets in peripheral blood mononuclear cell (PBMC) of patients vaccinated with a HER2 cytotoxic T lymphocyte (CTL) peptide-based vaccine.
II. To evaluate the feasibility of expanding HER2-specific effector T cells (TE) derived from HER2-specific TCM or TEM precursors in patients vaccinated with a HER2 CTL peptide-based vaccine and characterize their function.
SECONDARY OBJECTIVES:
I. To evaluate the safety of administering a HER2 CTL peptide-based vaccine in patients who are receiving trastuzumab and/or lapatinib (lapatinib ditosylate).
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with HER2+ stage IV breast cancer that have been maximally treated and not in a complete remission
- •Patients must have measurable disease per imaging studies performed within 60 days of enrollment as described below:
- •Extra skeletal disease that can be measured with conventional or spiral computed tomography (CT) techniques
- •Skeletal or bone-only disease that is measurable by fludeoxyglucose F 18 (FDG) positron emission tomography (PET) or magnetic resonance imaging (MRI)
- •Patients can be receiving trastuzumab and/or lapatinib and/or hormonal therapy and/or bisphosphonate therapy
- •HER2 overexpression in the primary tumor or metastasis by immunohistochemistry (IHC) of 3+, or documented gene amplification by fluorescent in situ hybridization (FISH) analysis
- •Patients must be human leukocyte antigen (HLA)-A2 positive
- •Eastern Cooperative Oncology Group (ECOG)/Zubrod scale of =< 1
- •Patients must be off immunosuppressive treatments (i.e., chemotherapy or systemic steroids) 3 weeks prior to first vaccine
- •Patients on trastuzumab must have a baseline left ventricular ejection fraction (LVEF) measured by multi gated acquisition scan (MUGA) or echocardiogram (ECHO) >= the lower limit of normal for the facility within 3 months of enrollment to study
- •Subjects of reproductive ability must agree to use contraceptives during the entire study period
排除标准
- •White blood cell (WBC) < 3000/mm^3
- •Hemoglobin (Hgb) < 10 mg/dl
- •Platelets < 100,000/mm^3
- •Serum creatinine > 2.0 mg/dl
- •Serum bilirubin > 1.5 x upper limit of normal
- •Any contraindication to receiving sargramostim (GM-CSF) based vaccine products
- •Concurrent enrollment in other treatment studies
- •New York Heart Association functional class III-IV heart failure, symptomatic pericardial effusion, or unstable angina
- •Pregnant or breast-feeding women
- •History of disorders associated with immunosuppression such as human immunodeficiency virus (HIV)
- •Active brain metastasis
研究组 & 干预措施
Treatment (HER-2/neu peptide vaccine)
Patients receive HER-2/neu peptide vaccine ID once monthly for 3 months.
干预措施: HER-2/neu peptide vaccine (Biological)
结局指标
主要结局
Quantification and characterization of HER2-specific TCM and TEM subsets in PBMC
时间窗: Up to 4 weeks
Wilson score 90% confidence intervals will be reported.
Evaluation of function and phenotype of HER2-specific TE cells derived from HER2-specific TCM and TEM subsets
时间窗: Up to 4 weeks
Wilson score 90% confidence intervals will be reported. Determined by flow cytometry and reported using descriptive statistics and graphical summaries.
次要结局
- The number of subjects reporting adverse events, evaluated according to the Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0(Up to 4 weeks)
- The percent of subjects recording adverse events, evaluated according to the CTEP CTCAE version 4.0(Up to 4 weeks)
研究者
Mary (Nora) Disis
Principal Investigator
University of Washington