Pancreatic Cancer Clinical Trial
Official title:
A Phase I, Safety Trial of Dendritic Cell Vaccine and Chemotherapy for Patients With Pancreatic Cancer
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.
This is a single center, exploratory pilot safety, open label, phase I trial that will
evaluate the combination of DC vaccination in 2 groups of patients when combined with
chemotherapy including FOLFIRINOX and gemcitabine+nab-paclitaxel in patients with pancreatic
cancer. The investigations will accrue 20 evaluable subjects over 20 months with 10 patients
in each group. Subjects will be assigned to group 1 or group 2 according to the subject's
disease stage.
The protocol will be conducted in two stages:
The 1st 3 patients will be enrolled to either group to receive DC vaccinations combined with
standard chemotherapy. A safety analysis will be performed after the first 3 patients have
completed 6 vaccines. If no vaccine dose-limiting toxicity occurs in any of the 3 patients
then the study will proceed with stage 2. Stage 2 will include the enrollment of the
remaining 17 patients.
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