NCT00003184已完成1 期
Phase I Trial Using a CD80-Modified Allogeneic Breast Cancer Cell Line to Vaccinate HLA-A2-Positive Women With Breast Cancer
Providence Cancer Center, Earle A. Chiles Research Institute2 个研究点 分布在 1 个国家开始时间: 1996年8月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Vaccines made from breast cancer cells may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vaccines made from breast cancer cells in treating women with metastatic breast cancer.
详细描述
OBJECTIVES:
- Determine the safety and toxicity of vaccination strategies employing a CD80-transfected allogeneic breast cancer cell line (MDA-MB-231).
- Assess the immunologic response of lymphocytes isolated from lymph nodes draining the vaccination site following a single dose of CD80-transfected MDA-MB-231.
- Assess the development of systemic immunity following multiple injections of CD80-transfected MDA-MB-231.
- Observe for tumor regression.
OUTLINE: This is a dose-escalation study.
Patients receive intradermal vaccinations containing CD80-transfected cells with or without sargramostim (GM-CSF) or with or without BCG. Vaccinations are administered every 2 weeks for 6 weeks and then monthly for 3 months. Patients may receive 1 of 2 different doses of GM-CSF. GM-CSF is administered with the vaccination, then every 12 hours for 7 days. Monthly vaccinations may continue as long as response is shown.
Cohorts of 5 patients each are treated at each dose/combination. Each cohort completes treatment before the next cohort is accrued.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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 proven metastatic breast cancer
- •Stage IV disease patients who have either been treated to maximal response or who have had high dose chemotherapy or a marrow ablative regimen (if they meet immunologic criteria and have not received more than 2 chemotherapy regimens for treatment of metastatic disease)
- •Patients with advanced stage disease who:
- •Received at least 1 standard chemotherapy regimen, but no more than 2, for treatment of metastatic disease
- •Refused chemotherapy
- •Refused or progressed despite hormonal therapy
- •Measurable or evaluable disease
- •Positive or negative for HLA-A2
- •Must have superficial inguinal or axillary lymph nodes that are free of tumor involvement and are surgically accessible
- •No symptomatic or acutely life threatening tumor that is judged likely to require intervention with alternative modalities within 3 months
- •No brain metastases
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Menopausal status:
- •Not specified
- •Performance status:
- •ECOG 0 or 1
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC greater than 3,000/mm^3
- •Not specified
- •BUN less than 25 mg/dL
- •Creatinine less than 1.8 mg/dL
- •Cardiovascular:
- •No ischemic or congestive cardiac disease requiring chronic medication
- •No New York Heart Association class III or IV heart disease
- •No evidence of ischemic change or ventricular ectopy (greater than 4/min) on electrocardiogram (EKG)
- •No evidence of type II arterial-ventricular block
- •No evidence of current cardiac disease by stress test and EKG
- •HIV negative
- •No active infection requiring treatment
- •No psychiatric illness
- •No history of seizure disorder
- •No other prior malignancy within the past 10 years except squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior specific or nonspecific immunotherapy, unless there is obvious progression of metastatic disease, and recovered
- •Chemotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy, unless there is obvious progression of metastatic disease, and recovered
- •Endocrine therapy:
- •At least 4 weeks since prior steroids, unless there is obvious progression of metastatic disease, and recovered
- •Radiotherapy:
- •Concurrent radiotherapy allowed for local control of disease
- •Not specified
排除标准
- 未提供
研究者
研究点 (2)
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