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
|ClinicalTrials.gov Identifier: NCT01410968|
Recruitment Status : Completed
First Posted : August 5, 2011
Last Update Posted : December 9, 2016
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Pancreatic Cancer||Drug: vacc. w/ Poly-ICLC & peptide-pulsed dendritic cells||Phase 1|
- Assess the safety of this treatment by evaluating the qualitative and quantitative toxicities in this group of patients.
- Determine the feasibility of generating dendritic cells and administering these cells as a vaccine to patients.
- Assess anti-tumor activity after vaccination, measured by change in tumor burden and overall survival.
- Assess immunological responses after vaccination (antigen-specific T cell cytokine production, antigen-specific T cell frequencies by tetramer analysis, and DTH reactions)
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2011|
|Primary Completion Date :||November 2013|
|Study Completion Date :||May 2015|
vaccination with investigational Poly-ICLC & peptide-pulsed dendritic cells
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.
- Feasibility [ Time Frame: 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 [ Time Frame: 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.
- Efficacy [ Time Frame: 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 [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01410968
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|