Pancreatic Tumor Cell Vaccine (GVAX), Cyclophosphamide, SBRT, and FOLFIRINOX in Patients With Resected Adenocarcinoma of the Pancreas

PHASE2CompletedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

October 29, 2012

Primary Completion Date

October 18, 2023

Study Completion Date

October 18, 2023

Conditions
Pancreatic Cancer
Interventions
DRUG

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.

BIOLOGICAL

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.

RADIATION

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."

DRUG

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."

Trial Locations (1)

21231

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

All Listed Sponsors
collaborator

The Skip Viragh Foundation

OTHER

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

NCT01595321 - Pancreatic Tumor Cell Vaccine (GVAX), Cyclophosphamide, SBRT, and FOLFIRINOX in Patients With Resected Adenocarcinoma of the Pancreas | Biotech Hunter | Biotech Hunter