A Feasibility and Safety Study of Vaccination With Poly-ICLC and Peptide-pulsed Dendritic Cells in Patients With Metastatic, Locally Advanced, Unresectable, or Recurrent Pancreatic Adenocarcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Feasibility
研究概览
简要总结
The purpose of this study is to provide a safety and feasibility basis for future studies addressing the hypothesis that subcutaneous vaccination with dendritic cells loaded with multiple antigenic epitopes expressed by pancreatic tumor in combination with systemic administration of Poly-ICLC (Hiltonol) will induce anti-tumor immunity.
详细描述
Primary Objectives
- Assess the safety of this treatment by evaluating the qualitative and quantitative toxicities in this group of patients.
- Determine the feasibility of generating dendritic cells and administering these cells as a vaccine to patients.
Secondary Objectives
- Assess anti-tumor activity after vaccination, measured by change in tumor burden and overall survival.
- Assess immunological responses after vaccination (antigen-specific T cell cytokine production, antigen-specific T cell frequencies by tetramer analysis, and DTH reactions)
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
研究组 & 干预措施
Vaccination
vaccination with investigational Poly-ICLC & peptide-pulsed dendritic cells
干预措施: vacc. w/ Poly-ICLC & peptide-pulsed dendritic cells (Drug)
结局指标
主要结局
Feasibility
时间窗: 2 years
Any protocol deviations will be described and the protocol schedule will be re-assessed to improve feasibility of implementation if necessary. The proportion of patients successfully completing the protocol (i.e., without deviations) will be reported with a one-sided 90% confidence interval. If the observed feasibility rate is \>0.80, the lower limit will be no lower than 0.60.
Safety
时间窗: 2 Years
All toxicities will be reported by type and grade and tabulated. To provide a safety characterization of the treatment regimen, it is important that common toxicities be observed in this phase of study for planning the next phase of research.
次要结局
- Efficacy(2 years)
- Immunological Responses(2 years)
研究者
Carolyn Britten
Chief, Hematology/Oncology Division
Medical University of South Carolina