19
Participants
Start Date
October 29, 2012
Primary Completion Date
October 18, 2023
Study Completion Date
October 18, 2023
Cyclophosphamide
Cyclophosphamide (Cy) 200 mg/m\^2 administered one day prior to GVAX (day 0). One dose will be given prior to SBRT and FOLFIRINOX and four additional doses after FOLFIRINOX completion for a total of 5 doses. Additional CY/GVAX boosts may be given every 6 months thereafter until disease recurrence.
GVAX Pancreas Vaccine
GVAX administered one day after Cy (day 1). One dose will be given prior to SBRT and FOLFIRINOX and four additional doses after FOLFIRINOX completion for a total of 5 doses. Additional CY/GVAX boosts may be given every 6 months thereafter until disease recurrence.
Stereotactic Body Radiation
"Cohort 1 and 2: SBRT (6.6 Gy per day, 33 Gy total dose) will be administered over 5 days within 6-10 weeks of pancreas surgery (Whipple).~Cohort 3: SBRT (6.6 Gy) will be administered over 5 days starting between 13-17 days after the first dose of CY/GVAX."
FOLFIRINOX
"FOLFIRINOX is given over six 28-day cycles, starting at least 1 weeks after SBRT.~FOLFIRINOX consists of the following drugs given IV on days 1 and 15 of each cycle:~Oxaliplatin (85 mg/m\^2), Irinotecan (180 mg/m\^2), Leucovorin (400 mg/m\^2), Fluorouracil (400 mg/m\^2 bolus followed by 2,400 mg/m\^2 continuous infusion over 46-48 hours);~modified FOLFIRINOX consists of the same regimen described above but without the 400 mg/m\^2 Fluorouracil bolus."
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore
The Skip Viragh Foundation
OTHER
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
OTHER