Phase II Randomized Study of CD34+ Derived or Peripheral Monocyte Derived Dendritic Cells Pulsed With MART-1 and gp100 Melanoma Antigens in Patients With High Risk Stage III or Completely Resected Metastatic Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
研究概览
简要总结
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy in treating patients who have high-risk stage III or completely resected metastatic melanoma.
详细描述
OBJECTIVES:
I. Determine the immunologic activity of CD34+ derived and peripheral monocyte derived dendritic cells pulsed with MART-1 and gp100 melanoma antigens in patients with high risk stage III or completely resected metastatic melanoma.
PROTOCOL OUTLINE: This is a randomized study. Patients receive dendritic cells derived either from peripheral monocytes or CD34+ cells.
Dendritic cells are pulsed with MART-1 and gp100 immunodominant HLA-A201 peptides prior to infusion, and are administered intralymphatically in the lower extremities for the first 2 courses. Beginning with courses 3 and 4, dendritic cells are administered subcutaneously in the anterior thigh. Dendritic cells are not administered to any extremity that has undergone lymph node dissection.
Patients are randomized to the following treatment arms:
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 16 Years 至 —（Child, 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