A Phase II Study Of Prostatic Acid Phosphatase-Pulsed Dendritic Cells (Provenge) In Combination With Bevacizumab In Patients With Serologic Progression Of Prostate Cancer After Definitive Local Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
研究概览
简要总结
Phase II trial to study the effectiveness of APC8015 combined with bevacizumab in treating patients who have undergone radiation therapy and/or surgery and who have progressive prostate cancer. Biological therapies such as APC8015 use different ways to stimulate the immune system and stop cancer cells from growing. Monoclonal antibodies such as bevacizumab can locate tumor cells and kill them without harming normal cells. Combining monoclonal antibody therapy with biological therapy may kill more cancer cells.
详细描述
OBJECTIVES:
I. Determine the efficacy of APC8015 (Provenge) and bevacizumab, in terms of decline in prostate-specific antigen (PSA) value and effect on PSA doubling time, in patients with progressive prostate cancer.
II. Determine any immune response in patients treated with this regimen. III. Determine the safety of this regimen in these patients.
OUTLINE:
Autologous dendritic cells (DCs) are harvested and pulsed with prostatic acid phosphatase-sargramostim fusion protein to produce APC8015 (Provenge). Patients receive APC8015 IV over 30 minutes and bevacizumab IV over 30-60 minutes on day 1. Treatment repeats every 14 days for 3 courses. Patients continue to receive bevacizumab alone every 14 days in the absence of disease progression or unacceptable toxicity.
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
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供