A Pilot Study of Cellular Immune Augmentation in Colon and Rectal Cancer Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Participants Exhibiting Immune Response
研究概览
简要总结
While new treatments for metastatic and recurrent colorectal cancer have become available over the past several years, this disease remains incurable with a limited life expectancy from the time of diagnosis. New strategies for treatment of disseminated colorectal cancer are needed. Under this proposal, patients with advanced colorectal cancer will receive Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) to stimulate endogenous dendritic cells and enhance anti-tumor immune mechanisms. This will be combined with standard chemotherapy and patients will be followed for response and overall survival. Detailed correlative laboratory analysis will also be performed to define the extent of dendritic cell and cellular immune system stimulation.
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
- •Patient must have: metastatic, disseminated or recurrent colon or rectal cancer
- •Patient to receive weekly or biweekly chemotherapy for at least 4 cycles (4 weeks) Examples include: 5FU or 5FU/leucovorin given once weekly Irinotecan (single agent) given once weekly 5FU/leucovorin/irinotecan given once weekly
- •Patient must be able to be taught to administer GM-CSF subcutaneously
- •Exclusion criteria:
- •Known allergic or other adverse reaction to GM-CSF
- •Chemotherapy administration more frequently than bi-weekly
- •Pregnant or lactating women
排除标准
- 未提供
研究组 & 干预措施
GM-CSF
Granulocyte-macrophage colony-stimulating factor (GM-CSF) 250ug/m^2 SQ QD with a cap of 500mcg SQ QD
干预措施: GM-CSF (Drug)
结局指标
主要结局
Participants Exhibiting Immune Response
时间窗: 24 Months
Immunological dendritic cell and cellular immune responses to GM-CSF administered in conjunction with chemotherapy for patients with advanced colorectal cancer.
次要结局
- Response Rates and Overall Survival.(24 Months)
研究者
Chao Family Comprehensive Cancer Center
Cancer Center
University of California, Irvine