7
Participants
Start Date
August 31, 2015
Primary Completion Date
April 24, 2017
Study Completion Date
April 24, 2017
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."
Charles A. Sammons Cancer Center, Dallas
Lead Sponsor
Baylor Research Institute
OTHER