A Phase I Trial of Intra Lesional RV-B7.1 Vaccine in the Treatment of Malignant Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
研究概览
简要总结
Phase I trial to study the effectiveness of vaccine therapy in treating patients who have unresectable metastatic melanoma. Vaccines may make the body build an immune response to kill tumor cells.
详细描述
OBJECTIVES:
I. Determine the maximum tolerated dose of the rV-B7.1 vaccine that elicits a host immune response and is associated with acceptable toxicity in patients with malignant metastatic melanoma.
II. Determine all clinical toxicities associated with this regimen in this patient population.
III. Determine the safety of this regimen in this patient population. IV. Assess evidence of host antimelanoma immune reactivity following this regimen.
V. Determine the effect of this regimen on T-cell immunity. VI. Assess the clinical response in this patient population receiving this regimen.
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