NCT02548169

Dendritic Cell Vaccine and Chemotherapy for Patients With Pancreatic Cancer

A Phase I, Safety Trial of Dendritic Cell Vaccine and Chemotherapy for Patients With Pancreatic Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Baylor Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
BIOLOGICAL	DC Vaccine + Standard of Care Chemotherapy	4 doses of DC vaccine at 2 weeks interval, combined with either: * Standard of care neoadjuvant folinic acid, oxaliplatin, irinotecan and 5- Fluorouracil (5FU) (FOLFIRINOX) regimen alone (6 cycles) * FOLRIRINOX regimen followed by 5-FU chemoradiation or Gemcitabine Chemoradiation * Gemcitabine + nab-paclitaxel The first vaccination will include one intradermal injection of 100 μL at 15 x106 cells/mL in the upper thigh and one subcutaneous injection of 1 mL (15 x 106 cells/mL) . The participants will receive 3 additional subcutaneous vaccinations, each injection of 1 mL at 15 x 106 cells/mL, at 2 weeks interval, on Day 2 of study weeks 3, 5 and 7. Participants will receive 2 booster DC vaccinations subcutaneously of 1 mL at 15x106 cells/mL.

Timeline

• Start date: 2015-08-01
• Primary completion: 2017-04-24
• Completion: 2017-04-24
• First posted: 2015-09-14
• Last updated: 2019-01-29

Locations

1 site across 1 country: United States