A Phase I/II Study of Active Immunotherapy With Carcinoembryonic Antigen RNA-Pulsed, Autologous Cultured Dendritic Cells for Patients With Breast Cancer Who Achieve a Complete Response After High Dose Chemotherapy and Stem Cell Support
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Evaluate the ability of active immunotherapy with carcinoembryonic antigen (CEA) RNA pulsed dendritic cells to induce CEA specific T cells in patients with metastatic breast cancer in complete remission following peripheral blood stem cell transplant.
研究概览
简要总结
RATIONALE: Immunotherapy using CEA-treated white blood cells may help a person's body build an immune response to and kill their tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of immunotherapy with CEA-treated white blood cells in treating patients with metastatic breast cancer who have achieved a partial or complete response after chemotherapy and peripheral stem cell transplantation.
详细描述
OBJECTIVES:
- Evaluate the ability of active immunotherapy with carcinoembryonic antigen (CEA) RNA pulsed dendritic cells to induce CEA specific T cells in patients with metastatic breast cancer in complete remission following peripheral blood stem cell transplant.
- Determine the clinical efficacy in terms of overall and recurrence free survival of immunotherapy with CEA RNA pulsed dendritic cells in this patients population.
OUTLINE: Dendritic cells are taken from the leukapheresis product obtained during the peripheral blood stem cell transplant procedure performed prior to treatment on this study. The dendritic cells are pulsed with carcinoembryonic antigen (CEA) RNA. Approximately 60-90 days after the peripheral blood stem cell transplant, patients receive CEA RNA pulsed dendritic cells IV every 3 weeks for a total of 4 doses. Patients undergo a second leukopheresis after the last dose of immunotherapy to obtain specimens for immunologic tests.
Patients are followed every 3 months for the first year and annually thereafter.
PROJECTED ACCRUAL: A total of 14-26 patients will be accrued for this study within 2 years.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed metastatic breast cancer that expresses carcinoembryonic antigen (CEA)
- •At least 25% of the tumor cells must stain positive for CEA with at least moderate intensity
- •Must have achieved either partial response or complete response after high dose chemotherapy and peripheral blood stem cell transplant
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Menopausal status:
- •Not specified
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •Greater than 6 months
- •Hematopoietic:
- •Absolute neutrophil count at least 1000/mm^3
- •Absolute lymphocyte count at least 1000/mm^3
- •Hemoglobin at least 9 mg/dL
- •Platelet count at least 100,000/mm^3
- •Bilirubin less than 2.0 mg/dL
- •No serious ongoing chronic or acute hepatic disease
- •Creatinine less than 2.5 mg/dL
- •Cardiovascular:
- •No serious ongoing chronic or acute cardiac disease (New York Heart Association class III or IV)
- •No serious ongoing chronic or acute pulmonary illness such as asthma, chronic obstructive pulmonary disease, or radiation or drug induced pneumonitis
- •No other prior or concurrent malignancy except nonmelanoma skin cancer or controlled superficial bladder cancer within the past 5 years
- •No history of autoimmune disease such as inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, scleroderma, or multiple sclerosis
- •No inflammatory bowel condition such as active infectious enteritis or eosinophilic enteritis
- •No active acute or chronic infection such as urinary tract infection, HIV, or viral hepatitis
- •Not pregnant or nursing
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •See Disease Characteristics
- •No concurrent immunotherapy
- •Chemotherapy:
- •See Disease Characteristics
- •No concurrent chemotherapy
- •Endocrine therapy:
- •At least 4 weeks since steroids
- •No concurrent steroid therapy
- •Radiotherapy:
- •No concurrent radiotherapy
- •Not specified
- •No concurrent immunosuppressive agents such as azathioprine or cyclosporine A
排除标准
- 未提供
结局指标
主要结局
Evaluate the ability of active immunotherapy with carcinoembryonic antigen (CEA) RNA pulsed dendritic cells to induce CEA specific T cells in patients with metastatic breast cancer in complete remission following peripheral blood stem cell transplant.
时间窗: Following administration of 4 IV vaccine doses (1 vaccine administered every 3 weeks)
次要结局
- Determine the clinical efficacy in terms of overall and recurrence free survival of immunotherapy with CEA RNA pulsed dendritic cells in this patients population.(Following administration of 4 IV vaccine doses (1 vaccine administered every 3 weeks))