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

Metastatic Pancreatic Cancer Clinical Trial

Official title: 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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

Primary Objectives

1. Assess the safety of this treatment by evaluating the qualitative and quantitative toxicities in this group of patients.

2. Determine the feasibility of generating dendritic cells and administering these cells as a vaccine to patients.

Secondary Objectives

1. Assess anti-tumor activity after vaccination, measured by change in tumor burden and overall survival.

2. Assess immunological responses after vaccination (antigen-specific T cell cytokine production, antigen-specific T cell frequencies by tetramer analysis, and DTH reactions) ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Metastatic Pancreatic Cancer
• Pancreatic Neoplasms

• NCT number: NCT01410968
• Study type: Interventional
• Source: Medical University of South Carolina
• Status: Completed
• Phase: Phase 1
• Start date: August 2011
• Completion date: May 2015