NCT00109863已完成2 期
Phase II Trial of Hu14.18-IL2 (EMD 273063) in Subjects With Advanced Melanoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Objective response rate and duration of response by clinical exam and radiology studies after every 2 courses
研究概览
简要总结
RATIONALE: Biological therapies, such as hu14.18-interleukin-2 fusion protein, may stimulate the immune system in different ways and stop tumor cells from growing.
PURPOSE: This phase II trial is studying how well hu14.18-interleukin-2 fusion protein works in treating patients with advanced melanoma.
详细描述
OBJECTIVES:
Primary
- Determine the clinical antitumor activity of hu14.18-interleukin-2 fusion protein in patients with advanced melanoma.
- Determine the duration of response in patients treated with this drug.
Secondary
- Determine the adverse events in patients treated with this drug.
- Determine the in vivo immunologic activation in patients treated with this drug.
- Determine the induction of anti-hu14.18 and anti-interleukin-2 antibodies in patients treated with this drug.
- Determine tumor antigen recognition by this drug in select patients with cutaneous metastatic tumors, as measured by binding of the drug to the cutaneous metastatic tumor and microscopic changes (including immune cell density and phenotype) of the tumor tissue.
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 —（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
结局指标
主要结局
Objective response rate and duration of response by clinical exam and radiology studies after every 2 courses
次要结局
- Immunologic activation induced by hu14.18-interleukin-2 after every 2 courses
- Adverse events by clinical assessment daily during treatment and weekly after completion of study treatment
- Induction of anti-idiotypic antibodies on days 1, 3, 4, and 8 of each course
研究者
研究点 (2)
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