Clinical trialPhase 2Active not recruiting
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
- Outcome
- Ongoing
- Phase
- Phase 2
- Status
- Active not recruiting
- Study type
- Interventional
- Start
- 20 April 2010
- Expected end
- August 2026
- Enrollment
- 71 participants
- Sites
- 1
- Primary outcomes
- Number of Participants Experiencing Drug-Related Adverse Events (AEs) Requiring Treatment Discontinuation; Number of Participants Experiencing Grade 3 or Above Drug-Related Adverse Events (AEs)
- Sponsor
- Other
- Results posted
- 2025-07-03
- Last update
- 26 August 2025
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Brief summary public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Number of Participants Experiencing Drug-Related Adverse Events (AEs) Requiring Treatment Discontinuation [121 Months]. Count Of Participants, Participants. Cohort 1 (J0810 Arm A) (n=8): 0; Cohort 1 (J0810 Arm B) (n=3): 0; Cohort 1 (J0810 Arm C) (n=2): 0; Cohort 2 (Vaccine Naive) (n=52): 3; Cohort 3 (J1568) (n=6): 0; Cohort 4 (J15237) (n=0): 0; Cohort 5 (J1766) (n=0): 0.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Number of Participants Experiencing Grade 3 or Above Drug-Related Adverse Events (AEs) [121 months]. Count Of Participants, Participants. Cohort 1 (J0810 Arm A) (n=8): 1; Cohort 1 (J0810 Arm B) (n=3): 0; Cohort 1 (J0810 Arm C) (n=2): 0; Cohort 2 (Vaccine Naive) (n=52): 7; Cohort 3 (J1568) (n=6): 0; Cohort 4 (J15237) (n=0): 0; Cohort 5 (J1766) (n=0): 0.