Adjuvant GVAX Vaccine Therapy in Patients With Pancreatic Cancer
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage I pancreatic cancer, stage II pancreatic cancer, pancreatic neoplasm, adenocarcinoma of the pancreas, stage IIl pancreatic cancer, adjuvant therapy, cancer vaccine, GVAX
Eligibility Criteria
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.
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
Sites / Locations
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Previously vaccinated with GVAX pancreas vaccine
GVAX pancreas vaccine naive
Participants receive booster vaccination every 6 months, given intradermally.
Participants will receive GVAX pancreas priming vaccinations once every month for a total of 3 months and every 6 months after that, given intradermally.