NCT00039325已完成1 期
A Phase I/II Trial Testing Mart-1 Genetic Immunization In Malignant Melanoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Optimal dose
研究概览
简要总结
RATIONALE: Vaccines made by inserting a laboratory-treated gene into a person's white blood cells may make the body build an immune response to kill tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of vaccine therapy and to see how well it works in treating patients with stage IV or recurrent malignant melanoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 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
Optimal dose
时间窗: 7 months
次要结局
- Clinical response (disease improvement or disease progression)(7 months)
- Immunological response (peptide-specific T cell generation, skin test immunohistology)(7 months)
- Safety of administering MART-1 adenovirus transduced dendritic cells(7 months)
研究者
研究点 (2)
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