Phase I Evaluation of Alpha-Type-1 DC-Based and cDC-Based Intralymphatic Vaccines in Patients With Metastatic Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 4
- 主要终点
- Safety of intralymphatic autologous type-1-polarized dendritic cell vaccine and autologous mature dendritic cell vaccine
研究概览
简要总结
RATIONALE: Vaccines made from a person's dendritic cells mixed with tumor peptides and proteins may help the body build an effective immune response to kill tumor cells. Infusing the vaccine directly into the lymphatic system may cause a stronger immune response and kill more tumor cells.
PURPOSE: This randomized phase I trial is studying the side effects and best dose of two dendritic cell vaccines in treating patients with stage III or stage IV melanoma.
详细描述
OBJECTIVES:
Primary
- Compare the safety of intralymphatic autologous type-1-polarized dendritic cell vaccine vs autologous mature dendritic cell vaccine loaded with antigenic peptides and proteins in patients with stage III or IV melanoma.
Secondary
- Determine peripheral blood CD8+ and CD4+ T-cell responses to HLA-presented melanoma epitopes and autologous tumor cells using interferon gamma and interleukin-5 ELISPOT assay.
- Compare the delayed-type hypersensitivity (DTH) responses to these regimens and DTH to autologous tumor lysates in these patients.
- Compare the DTH response to keyhole limpet hemocyanin and pan-DR epitope (PADRE) in these patients.
- Correlate treatment-associated changes in immune response with clinical outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
研究组 & 干预措施
peptide-pulsed type-1-polarized dendritic cells
intralymphatic vaccination with peptide-pulsed type-1-polarized dendritic cells (aDC1)
干预措施: polarized dendritic cells (Biological)
peptide-pulsed mature non-polarized dendritic cells (cDCs)
intralymphatic vaccination with peptide-pulsed mature non-polarized dendritic cells (cDCs)
干预措施: non-polarized dendritic cells (Biological)
结局指标
主要结局
Safety of intralymphatic autologous type-1-polarized dendritic cell vaccine and autologous mature dendritic cell vaccine
时间窗: 7 years
次要结局
- Assess immune responses to each dendritic cell vaccine outcome(7)
研究者
Pawel Kalinski
Professor of Surgery and Immunology
University of Pittsburgh