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
- Conditions
- Metastatic Pancreatic Cancer
- Interventions
- Drug: vacc. w/ Poly-ICLC & peptide-pulsed dendritic cells
- Registration Number
- NCT01410968
- Lead Sponsor
- Carolyn Britten
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vaccination vacc. w/ Poly-ICLC & peptide-pulsed dendritic cells vaccination with investigational Poly-ICLC \& peptide-pulsed dendritic cells
- Primary Outcome Measures
Name Time Method Feasibility 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 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.
- Secondary Outcome Measures
Name Time Method Efficacy 2 years Graphical displays of tumor size (as a percentage of baseline) over time. A subject's best response (i.e., complete response, partial response, stable disease or progressive disease) will be reported. Time to disease progression from baseline for each patient will be reported. Time to death will be reported in the same manner. These results will be summarized using proportions with confidence intervals and Kaplan-Meier curves, although the confidence limits are expected to be wide based on the small sample size.
Immunological Responses 2 years Antigen-specific T cell frequencies, antigen-specific T cell cytokine production and DTH reactions will be assessed.
For T cell-based functional analysis, each measurement will be performed with the three peptides telomerase, CEA, and survivin. Transformation of the continuous outcomes will be logged. Post measurements will be normalized by the baseline value (i.e. we will subtract the baseline value from each of the post vaccination measurements after the log transformations). Each of these measures will be displayed graphically over time for each patient to observe modulations in these measures. If appropriate based on the distribution of values over time, linear longitudinal regression will be used to model the change in these outcomes over time. Appropriateness will be based on the consistency of trends across patients.
Trial Locations
- Locations (1)
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States