Dendritic Cell Vaccine and Chemotherapy for Patients With Pancreatic Cancer
Summary
The primary objective is to confirm clinical safety and feasibility of combining the antigen-loaded Dendritic Cell (DC) vaccine with chemotherapy including folinic acid, oxaliplatin, irinotecan and 5-Fluorouracil (5FU) (FOLFIRINOX) and nab-paclitaxel/gemcitabine in patients with pancreatic cancer. The secondary objectives of this trial are to determine preliminary clinical efficacy based on response rates, overall survival and progression free survival compared with historic control, and surgical conversion rate as defined as percent of locally advanced (unresectable) patients achieving resectability within 6 months of treatment initiation. Also, to identify vaccine immunogenicity by measuring acquired, T cell-mediated immune activating events post-vaccination and to correlate clinical response with acquired immune responses.
Timeline
- Start
- 2015-08
- Primary completion
- 2017-04-24
- Completion
- 2017-04-24
Outcome
Outcome not reported
Stopped (Business): “The study was stopped because of loss of funding and no safety issues”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | DC vaccine | Vaccine | 1.5e+07 cells | Intravenous |
| Comparator | Gemcitabine | Small molecule | — | — |
| Comparator | Irinotecan | Small molecule | — | — |
| Comparator | Leucovorin | Small molecule | — | — |
| Comparator | Nab-paclitaxel | Small molecule | — | — |
| Comparator | Oxaliplatin | Small molecule | — | — |
| Comparator | fluorouracil | Small molecule | — | — |