NCT00081172已完成2 期
A Phase II Trial Of Lu Radiolabeled Monoclonal Antibody HuJ591-GS (Lu-J591) In Patients With Metastatic Androgen-Independent Prostate Cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 3
- 主要终点
- Biochemical response as measured by prostate-specific antigen level at 8 weeks after treatment
研究概览
简要总结
RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver radioactive tumor-killing substances to them without harming normal cells.
PURPOSE: This phase II trial is studying how well radiolabeled monoclonal antibody works in treating patients with progressive metastatic androgen-independent adenocarcinoma (cancer) of the prostate.
详细描述
OBJECTIVES:
Primary
- Determine the prostate-specific antigen (PSA) response rate in patients with progressive metastatic androgen-independent adenocarcinoma of the prostate treated with lutetium Lu 177 monoclonal antibody J591.
- Determine the measurable disease response rate in patients treated with this drug.
Secondary
- Determine the toxicity of this drug in these patients.
- Determine the duration of biochemical PSA and/or measurable disease response in patients treated with this drug.
- Determine the incidence of human anti-J591 antibody (HAHA) response in patients treated with this drug.
- Correlate hematological toxicity of this drug with bone marrow involvement (bone scan index) in these patients.
- Determine the survival rate in patients treated with this drug.
- Determine the targeting of this drug to known tumor sites in these patients.
- Determine the tumor-absorbed radiation dose in patients treated with this drug.
研究设计
- 研究类型
- Interventional
- 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
Biochemical response as measured by prostate-specific antigen level at 8 weeks after treatment
次要结局
未报告次要终点
研究者
研究点 (3)
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