NCT01410968

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Carolyn Britten · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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)

Conditions

• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	vacc. w/ Poly-ICLC & peptide-pulsed dendritic cells	Intradermal injection of 1x107 peptide-pulsed dendritic cells followed by intramuscular injection of 30 micrograms per kilogram Poly-ICLC on days 0, 14, 28 and 42. Additional dose of 30 micrograms per kilogram Poly-ICLC on days 3, 17, 31 and 45. Treatment given via one 56-day cycle. Leukapheresis performed at baseline for dendritic cell generation.

Timeline

• Start date: 2011-08-01
• Primary completion: 2013-11-01
• Completion: 2015-05-01
• First posted: 2011-08-05
• Last updated: 2016-12-09

Locations

1 site across 1 country: United States