Clinical trialPhase 1Completed
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
- Outcome
- Finished, no results posted
- Phase
- Phase 1
- Status
- Completed
- Study type
- Interventional
- Start
- August 2011
- Expected end
- May 2015
- Enrollment
- 12 participants
- Sites
- 1
- Primary outcomes
- Feasibility; Safety
- Sponsor
- Other
- Results posted
- No
- Last update
- 9 December 2016
These are registry fields. A trial card, with population, design, endpoints and result direction each tied to a quote, is not in the data yet.
Ask this document
Answers come only from this document’s own text, as highlighted quotes. If it doesn’t say, you are told so instead of given a guess.
Try
Source text
Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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)