Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-25 @ 3:10 PM
Study NCT ID:
NCT01410968
Status:
COMPLETED
Last Update Posted:
2016-12-09
First Post:
2011-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief 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
Sponsor:
Carolyn Britten
Organization:
Study Overview
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
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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)
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: