A Safety and Bioactivity Study of Combination Therapy With Trastuzumab, Cyclophosphamide, and an Allogeneic GM-CSF-Secreting Breast Tumor Vaccine for the Treatment of Patients With High Risk/ Metastatic HER-2/Neu- Overexpressing Breast Cancer With No Evidence of Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of Participants With Immunologic Response as Determined by Delayed-type Hypersensitivity (DTH) Response to HER2/Neu-derived Peptides
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vaccines made from gene-modified tumor cells may help the body build an immune response to kill tumor cells. Giving trastuzumab together with cyclophosphamide and vaccine therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving trastuzumab together with cyclophosphamide and vaccine therapy in treating patients with high-risk or metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- To evaluate the safety of allogeneic sargramostim (GM-CSF)-secreting breast cancer vaccine in combination with trastuzumab (Herceptin®) and cyclophosphamide in patients with high-risk or metastatic HER2/neu-overexpressing breast cancer.
- To measure the HER2/neu-specific CD4+ T-cell response by delayed-type hypersensitivity.
- To measure the magnitude of HER2/neu-specific CD8+ T-cell responses by ELISPOT.
Secondary
- To assess the impact of trastuzumab on immune priming in vivo by IHC.
- To measure the impact of cyclophosphamide pretreatment on CD4+CD25+ regulatory T cells by flow cytometry.
- To determine the time to disease progression.
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
- 18 Years 至 120 Years（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
研究组 & 干预措施
Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine
Participants receive Trastuzumab (T), Cyclophosphamide (CY), and an allogeneic GM-CSF-secreting whole cell breast cancer vaccine
干预措施: allogeneic GM-CSF-secreting breast cancer vaccine (Biological)
Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine
Participants receive Trastuzumab (T), Cyclophosphamide (CY), and an allogeneic GM-CSF-secreting whole cell breast cancer vaccine
干预措施: trastuzumab (Biological)
Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine
Participants receive Trastuzumab (T), Cyclophosphamide (CY), and an allogeneic GM-CSF-secreting whole cell breast cancer vaccine
干预措施: cyclophosphamide (Drug)
Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine
Participants receive Trastuzumab (T), Cyclophosphamide (CY), and an allogeneic GM-CSF-secreting whole cell breast cancer vaccine
干预措施: flow cytometry (Other)
Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine
Participants receive Trastuzumab (T), Cyclophosphamide (CY), and an allogeneic GM-CSF-secreting whole cell breast cancer vaccine
干预措施: immunoenzyme technique (Other)
Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine
Participants receive Trastuzumab (T), Cyclophosphamide (CY), and an allogeneic GM-CSF-secreting whole cell breast cancer vaccine
干预措施: immunohistochemistry staining method (Other)
Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine
Participants receive Trastuzumab (T), Cyclophosphamide (CY), and an allogeneic GM-CSF-secreting whole cell breast cancer vaccine
干预措施: laboratory biomarker analysis (Other)
Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine
Participants receive Trastuzumab (T), Cyclophosphamide (CY), and an allogeneic GM-CSF-secreting whole cell breast cancer vaccine
干预措施: pharmacological study (Other)
Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine
Participants receive Trastuzumab (T), Cyclophosphamide (CY), and an allogeneic GM-CSF-secreting whole cell breast cancer vaccine
干预措施: biopsy (Procedure)
结局指标
主要结局
Number of Participants With Immunologic Response as Determined by Delayed-type Hypersensitivity (DTH) Response to HER2/Neu-derived Peptides
时间窗: 4 years
Safety as Assessed by Number of Participants Experiencing Toxicity
时间窗: 4 years
Safety as assessed by number of participants who experienced drug-related local and systemic toxicity, as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v3.0) in response to CY-modulated immunization with a novel breast cancer vaccine in the setting of weekly Trastuzumab therapy.
次要结局
- Clinical Benefit as Assessed by Number of Participants With Progression-free Survival(4 years)