NCT00389610

Adjuvant GVAX Vaccine Therapy in Patients With Pancreatic Cancer

A Safety and Efficacy Trial of Vaccine Boosting With Lethally Irradiated Allogeneic Pancreatic Tumor Cells Transfected With the GM-CSF Gene for the Treatment of Pancreatic Adenocarcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, phase II trial study of adjuvant GVAX pancreas vaccine in patients with pancreatic cancer.

Detailed description

Eligible participants will receive by intradermal administration the GVAX pancreas vaccine consisting of two irradiated allogeneic pancreatic tumor cell lines transfected with the granulocyte macrophage-colony stimulating factor (GM-CSF) gene. There will be two cohorts of research participants: 1. Participants previously vaccinated with GVAX pancreas vaccine. These participants will receive booster vaccinations as a continuation of care. Vaccination repeats every 6 months in the absence of disease progression or unacceptable toxicity. 2. Participants who were not previously vaccinated with GVAX pancreas vaccine (vaccine naive). These participants received priming vaccinations once a month for 3 months followed by booster vaccinations every 6 months.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
BIOLOGICAL	GVAX pancreas vaccine	Given intradermally

Timeline

• Start date: 2006-09-11
• Primary completion: 2021-10-11
• Completion: 2022-12-10
• First posted: 2006-10-19
• Last updated: 2023-10-26
• Results posted: 2022-09-02

Locations

1 site across 1 country: United States