NCT01088789

Boost GVAX Pancreas Vaccine With or Without CY in Patients With Pancreas Cancer

A Safety and Feasibility Trial of Boost Vaccinations of a Lethally Irradiated, Allogeneic Pancreatic Tumor Cell Vaccine Transfected With the GM-CSF Gene Given Alone or in Combination With Either a Single Intravenous Dose or Daily Metronomic Oral Doses of Cyclophosphamide for the Treatment of Surgically Resected Pancreatic Adenocarcinoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and feasibility of long term boost vaccination of a lethally irradiated, allogenic pancreatic tumor cell vaccine transfected with the granulocyte macrophage colony-stimulating factor (GM-CSF) gene (GVAX Pancreas Vaccine) alone or given in combination with either a single intravenous dose or daily metronomic oral doses of cyclophosphamide for the treatment of patients with surgically resected adenocarcinoma of the pancreas.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m\^2 CY administered IV on day 0 of each Cycle (every 6 months). Cohort 2 patients will receive 200mg/m\^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days) and Day 0 of subsequent Cycles (every 6 months).
DRUG	Cyclophosphamide Pill	Cohort 1 patients (J0810 Arm C) will receive 50mg oral CY once a day starting 28 days prior to GVAX and for 28 days post-GVAX (every 6 months).
BIOLOGICAL	GVAX Pancreas Vaccine	Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).

Timeline

• Start date: 2010-04-20
• Primary completion: 2024-07-17
• Completion: 2026-08-01
• First posted: 2010-03-17
• Last updated: 2025-08-26
• Results posted: 2025-07-03

Locations

1 site across 1 country: United States