Allogeneic Adoptive Immunochemotherapy For Treatment Of Renal Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 2
- 主要终点
- Number of patients with treatment related mortality
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells can reject the body's normal tissues. Alemtuzumab and tacrolimus may prevent this from happening.
PURPOSE: Phase II trial to study the effectiveness of combining fludarabine and cyclophosphamide with alemtuzumab in treating patients who are undergoing allogeneic stem cell transplantation for recurrent or metastatic renal cell carcinoma (kidney cancer).
详细描述
OBJECTIVES:
- Determine the safety and feasibility of fludarabine, cyclophosphamide, and alemtuzumab in patients with recurrent or metastatic renal cell carcinoma undergoing HLA-matched allogeneic stem cell transplantation.
OUTLINE: This is a pilot, multicenter study.
- Conditioning: Patients receive fludarabine IV over 30 minutes on days -6 to -2, cyclophosphamide IV over 2 hours on days -6 and -5, and alemtuzumab IV on days -4 to -2.
- Allogeneic transplantation: Allogeneic stem cells are infused on day 0. Patients receive graft-vs-host disease prophylaxis with tacrolimus IV or orally for approximately 30 days.
Patients are followed weekly for 100 days and then at 6, 12, 18, 24, 36, 48, and 60 months after transplantation.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 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
结局指标
主要结局
Number of patients with treatment related mortality
时间窗: 100
次要结局
未报告次要终点
研究者
Helen Heslop
Professor
Baylor College of Medicine