PHASE II STUDY OF MONOCLONAL ANTIBODY 17-1A WITH GM-CSF IN TREATMENT OF 5-FU RESISTANT COLORECTAL CANCER
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Colony-stimulating factors such as G-CSF may increase the number of immune cells found in bone marrow or peripheral blood, and may help a person's immune system kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy plus G-CSF in treating patients with metastatic colorectal cancer that has not responded to treatment with fluorouracil.
详细描述
OBJECTIVES: I. Assess the response rate, duration of response, and survival after treatment with monoclonal antibody 17-1A and granulocyte-macrophage colony stimulating factor in patients with colorectal cancer metastatic to nonhepatic sites and refractory to fluorouracil. II. Describe the toxicities associated with this regimen. III. Assess the quality of life in these patients.
OUTLINE: Biological Response Modifier Therapy. Colorectal antigen 17-1A murine monoclonal antibody, MOAB 17-1A, NSC-377963; Granulocyte-macrophage colony stimulating factor (Immunex), GM-CSF, NSC-613795.
PROJECTED ACCRUAL: There will be 30 evaluable patients accrued into this study over approximately 1 year.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究者
James Ahlgren
Principal Investigator
George Washington University