Immunotherapy of Colon Cancer With Autologous Perchloric Soluble Tumors Extracts
试验速览
- 阶段
- 3 期
- 发起方
- 试验地点
- 2
- 主要终点
- Recurrence
研究概览
简要总结
RATIONALE: Immunotherapy uses different ways to stimulate the immune system and stop cancer cells from growing. Immunotherapy biological extracts may be useful as adjuvant therapy in treating patients who have had surgery for breast cancer, colon cancer, or melanoma.
PURPOSE: Phase III trial to study the effectiveness of Corynebacterium granulosum extract as maintenance immunotherapy following surgery in treating patients with breast cancer, colon cancer, or melanoma.
详细描述
OBJECTIVES:
- Determine the survival of patients with colon cancer, breast cancer, or melanoma with minimal residual disease after surgical resection treated with maintenance immunotherapy using Corynebacterium granulosum P40.
- Determine leucocyte adherence inhibition, an indication of metastases, over time in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified by center and are matched with case-controls by disease type and stage.
Beginning 2 weeks after surgical resection, patients receive Corynebacterium granulosum P40 subcutaneously weekly for 6 weeks, followed by rest for 3 months. Treatment continues for life.
Patients are followed for survival.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of colon cancer, breast cancer, or melanoma with minimal residual disease (at least 90% of tumor mass resected) after surgical resection
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Menopausal status:
- •Not specified
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Not specified
- •Not specified
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •See Disease Characteristics
排除标准
- 未提供
结局指标
主要结局
Recurrence
Response to study parameters
Survival rate
次要结局
未报告次要终点