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

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

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.

1. Inclusion Criteria:

   A. previously vaccinated subjects must receive Gvax vaccine previously

   B. naïve and previously vaccinated subjects must meet the following criteria:

   • have a history of surgically resected pathologic stage 1,2 or 3 adenocarcinoma of the head, neck, tail, or uncinate of the pancreas
   • received the last anti-cancer therapy at least 28 days ago.
   • provide informed consent.
   • have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
   • have adequate hematologic function (Hemoglobin ≥ 9 gm/dl, Absolute neutrophil count (ANC) ≥ 1500 #/cu mm, platelets ≥100,000 K/cu mm)
   • have adequate renal function (Serum creatinine ≤ 2 mg/dL).
   • have adequate hepatic function (Bilirubin ≤ 2.0 mg/dL, unless known Gilbert's Syndrome; Aspartate Aminotransferase (AST), Alanine transaminase (ALT) and amylase ≤ 2x upper limit of normal: Alk Phosphatase ≤ 5x upper limit of normal.)
   • agree to use adequate birth control, if of childbearing potential.

2. Exclusion criteria:

   • radiographical evidence of pancreatic cancer disease recurrence
   • documented history of autoimmune diseases including systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis
   • uncontrolled medical problems
   • systemic steroid therapy within 28 days before vaccine administration
   • anticipated need for systemic steroid therapy within 28 days after vaccine administration
   • evidence of active infections
   • pregnant