NCT01595321

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

Pilot Study Evaluating Allogeneic GM-CSF-Transduced Pancreatic Tumor Cell Vaccine (GVAX) and Low Dose Cyclophosphamide With Fractionated Stereotactic Body Radiation Therapy (SBRT) and FOLFIRINOX Chemotherapy in Patients With Resected Adenocarcinoma of the Pancreas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years – 76 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to estimate safety of GVAX Pancreas Vaccine (GVAX) with immune modulating doses of cyclophosphamide (Cy) followed by SBRT and FOLFIRINOX chemotherapy in pancreatic cancer patients after surgery.

Detailed description

This study enrolled patients with surgically resected adenocarcinoma of the pancreas who had titanium clips placed at the time of surgery in order to guide SBRT treatment. Enrollment was based on traditional 3+3 design with grade 3-4 diarrhea and/or neutropenia defined as the dose limiting toxicity (DLT) within the first 2 cycles (8 weeks) of FOLFIRINOX. The first group of 3 patients (Cohort 1) received SBRT and full dose FOLFIRINOX. The second group of 4 patients (Cohort 2) received SBRT and modified FOLFIRINOX, and the third group of 12 patients (Cohort 3) received SBRT and modified FOLFIRINOX as well as Cy/GVAX vaccinations. Cy/GVAX (patients 8-19): cyclophosphamide (Cy) at 200 mg/m\^2 intravenously over 30 minutes the day before each vaccine. Each vaccination (GVAX) consists of six total intradermal injections of vaccine, two each in the upper right and left thighs, and two in the upper non-dominant arm. Each injection consists of approximately 2.5x10\^8 cells of each cell line (PANC 6.03/PANC 10.05) for a total of 5x10\^8 cells. The first dose of Cy/GVAX was given within 6-10 weeks from surgery. Adjuvant SBRT was given 13-17 days after the first dose of Cy/GVAX. Patients receive 5 days of SBRT (6.6 gray (Gy) daily for 33 Gy total) to the tumor bed as delineated by surgical clips placed by the surgeon. Six 28-day cycles of FOLFIRINOX, starting at least one week after completion of SBRT. This was permitted to be given locally. Patients were evaluated for dose limiting toxicities (DLTs) within the first 2 cycles (8 weeks). Cy/GVAX #2-5 was given every 28 days (+/- 3 days), starting 35 days (+/- 7 days) after completion of FOLFIRINOX. Patients without evidence of recurrence could then qualify for additional Cy/GVAX boosts every 6 months (every 12 months with Amendment #10) until disease recurrence, toxicity, withdrawal, or death.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-10-29
• Primary completion: 2023-10-18
• Completion: 2023-10-18
• First posted: 2012-05-10
• Last updated: 2024-08-14
• Results posted: 2024-08-14

Locations

1 site across 1 country: United States