NCT00068614已完成1 期
A Phase I Trial Evaluating The Safety Of Intramuscular Injections Of HER-2 Protein AUTOVAC (PX104.1.6) In Patients With Breast Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of HER-2 protein vaccine in treating women who have breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the safety of HER-2 protein AutoVac™ in women with breast cancer.
Secondary
- Determine the ability of this drug to bypass the tolerance to the HER-2 self-protein by raising HER-2 antibodies in these patients.
- Determine the kinetics of the immune response to HER-2/neu in patients treated with this drug.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the breast, meeting criteria for 1 of the following:
- •Metastatic disease currently in complete or partial response or stable disease
- •Have been receiving a stable endocrine therapy regimen (e.g., aromatase inhibitor, tamoxifen, fulvestrant, or gonadotropin-releasing hormone agonist) for at least 30 days OR status post oophorectomy
- •Completed a course of local and adjuvant systemic therapy for high-risk stage II or III disease (i.e., anticipated 5-year relative survival is no greater than 50%) meeting any of the following staging criteria:
- •Stage IIB with involvement of at least 4 nodes
- •Stage IIIA (T3 disease with involvement of at least 4 nodes)
- •Any stage IIIB or IIIC disease
- •Stage IV with no evidence of disease (e.g., prior resection of local chest wall recurrence with no evidence of disease elsewhere)
- •1+, 2+, or 3+ HER2/neu expression by immunohistochemistry
- •Treatment with trastuzumab (Herceptin®) not clinically indicated
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Menopausal status
- •Not specified
- •Performance status
- •Life expectancy
- •At least 6 months
- •Hematopoietic
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 10 g/dL
- •Absolute neutrophil count at least 1,500/mm^3
- •ALT or AST no greater than 2.5 times upper limit of normal (ULN) (5 times ULN for patients with liver metastases)
- •Bilirubin no greater than 2 mg/dL (unless due to Gilbert's disease)
- •Creatinine no greater than 2 mg/dL
- •Cardiovascular
- •No history of significant cardiovascular disease
- •No myocardial infarction within the past 6 months
- •No poorly controlled cardiac arrhythmia
- •No New York Heart Association class III or IV heart disease
- •LVEF at least 50% by MUGA
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other malignancy except basal cell skin cancer or adequately treated carcinoma in situ of the cervix
- •No concurrent severe autoimmune disease
- •No other clinically significant or serious medical disease that would preclude study participation or compromise patient safety or the results of this study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 4 months since prior trastuzumab
- •No prior anticancer vaccine therapy
- •No concurrent trastuzumab
- •No concurrent immunomodulators (e.g., thalidomide or interferons/interleukins)
- •Chemotherapy
- •More than 4 weeks since prior chemotherapy
- •No concurrent low-dose methotrexate or cyclophosphamide
- •No concurrent cytotoxic chemotherapy
- •Endocrine therapy
- 另有 14 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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