A Non-Randomized Multicenter Phase I/II Study Of Active Specific Immunotherapy In Patients With Stage II and Stage III Colon Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 试验地点
- 4
研究概览
简要总结
RATIONALE: Vaccines made from a patient's white blood cells and tumor cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy combined with leucovorin and fluorouracil in treating patients who have undergone surgery to completely remove stage II or stage III colon cancer.
详细描述
OBJECTIVES:
- Determine safety and immunogenicity of adjuvant autologous tumor cell vaccine in patients with completely resected stage II or III adenocarcinoma of the colon.
OUTLINE: This is a multicenter study. Patients are stratified according to disease stage (II vs III).
Beginning 28-35 days after total surgical resection, patients receive adjuvant autologous tumor cell vaccine intradermally once weekly for 3 vaccinations. The first 2 vaccinations also contain BCG. Patients with stage II disease receive a fourth vaccination 6 months after surgical resection.
Beginning 10-17 days after the third vaccination, patients with stage III disease receive adjuvant leucovorin calcium IV and fluorouracil IV on days 1-5. Chemotherapy continues every 28-35 days for a total of 6 courses. These patients also receive a fourth vaccination 1 month after the completion of chemotherapy.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed stage II or III primary adenocarcinoma of the colon
- •Completely resected within the past 28-35 days, at which time tumor tissue is harvested for vaccine production
- •No residual or metastatic disease
- •No more than 1 malignant invasive primary colon cancer
- •No tumor originating in the rectum (i.e., inferior tumor margin must not be at or below the peritoneal reflection)
- •No perforated tumors
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC greater than 4,000/mm^3
- •Platelet count greater than 100,000/mm^3
- •Hemoglobin greater than 10.0 g/dL
- •Bilirubin normal
- •SGOT normal
- •Alkaline phosphatase normal
- •No severe hepatic disease that would preclude study
- •Creatinine less than 1.5 times upper limit of normal
- •No severe renal disease that would preclude study
- •Cardiovascular:
- •No prosthetic cardiac valves
- •No recent vascular prosthesis
- •No postsurgical cardiovascular complication
- •No severe cardiovascular disease that would preclude study
- •No postsurgical pulmonary complication
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No insulin-dependent diabetes mellitus
- •No severe systemic disease that would preclude study
- •No congenital or acquired immune deficiency disease
- •No history of chronic ulcerative colitis, Crohn's disease, Gardner's syndrome, or Turcot's syndrome
- •No other prior malignancy except curatively treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
- •No ongoing infection requiring systemic antibiotics
- •No severe postoperative complication that would preclude study
- •Carcinoembryonic antigen normal
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No other concurrent investigational immunotherapy
- •Chemotherapy:
- •No prior systemic chemotherapy
- •No other concurrent investigational chemotherapy
- •Endocrine therapy:
- •No concurrent steroids
- •Radiotherapy:
- •No prior radiotherapy
- •No concurrent investigational radiotherapy
- •See Disease Characteristics
- 另有 3 项未显示
排除标准
- 未提供