NCT00908141已完成2 期
Immunologic Effects of GM-CSF (Sargramostim, Leukine®) in Patients With Biochemically-relapsed Prostate Cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Prostate Specific Antigen (PSA) Response
研究概览
简要总结
RATIONALE: Colony stimulating factors, such as GM CSF, may increase the number of immune cells found in bone marrow or peripheral blood. It is not yet known which GM-CSF regimen is more effective in treating patients with prostate cancer.
PURPOSE: This randomized phase II trial is studying how well GM-CSF works in treating patients with relapsed prostate cancer.
详细描述
OBJECTIVES:
Primary
- To determine the ability of sargramostim (GM-CSF) to increase the number and activation of dendritic cells (DC) in patients with biochemically relapsed prostate cancer.
Secondary
- To determine the effect of administration schedule and hormonal state on sargramostim-induced DC number and activation in these patients.
- To correlate the effects of sargramostim on DC number and activation with effects on prostate-specific antigen (PSA) modulation.
- To determine whether sargramostim administration generates antiprostate cancer immune responses in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 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
结局指标
主要结局
Prostate Specific Antigen (PSA) Response
时间窗: post treatment at 9 weeks
The number of patients with PSA modulation defined as PSA decline of at least 50%
次要结局
未报告次要终点
研究者
研究点 (2)
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