Vaccination With Autologous Dendritic Cells Pulsed With Allogenous Melanoma Lysate (MelCancerVac) for Treatment of Patients With Advanced Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
研究概览
简要总结
Dendritic cells loaded with tumor antigens induce cytotoxic T-cells which have been proved capable of killing both melanoma and breast cancer cells. Melanoma and colorectal cancer cells express some common antigens. Hence it is possible to use melanoma lysate to load the dendritic cells with tumor antigens similar to the antigens expressed by the patients' colorectal cancer cells.
The patient receives 10 vaccinations with 14 days between each. The parameters for effect are changes in tumor/metastasis size measured with computed tomography (CT), decrease in serum concentration of carcinoembryonic antigen (CEA), performance status measured by the World Health Organization (WHO) criteria, and Quality of Life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Verified cancer of colon or rectum
- •No chemo- or radiation therapy in 6 weeks
- •Performance status 0, 1, or 2 (WHO criteria)
- •Adequate function of the kidneys, liver, lungs, and heart
- •Adequate function of the hematopoietic system and the coagulation system
- •Negative pregnancy test and adequate birth control for fertile women
排除标准
- •Pregnancy
- •Uncontrolled infection
