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This study evaluated the GVAX pancreatic cancer vaccine, given with or without cyclophosphamide, in patients with Stage I or II pancreatic cancer that could be removed by surgery. It was open to newly diagnosed patients with surgically resectable pancreatic adenocarcinoma in adequate general health. Run by Johns Hopkins' Sidney Kimmel Comprehensive Cancer Center, the study was conducted in Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
DISEASE CHARACTERISTICS: * Newly diagnosed adenocarcinoma of the head, neck, or uncinate process of the pancreas * Stage I or II disease * Surgically resectable disease (R0 or R1) by spiral CT scan * No distant metastases * A clear fat plane is present around the celiac and superior mesenteric arteries * Patent superior mesenteric and portal veins * Candidate for a pancreaticoduodenectomy PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Hemoglobin ≥ 9 g/dL * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Serum creatinine ≤ 2 mg/dL * AST and ALT ≤ 2 times upper limit of normal (ULN) * Amylase ≤ 2 times ULN * Alkaline phosphatase ≤ 5 times ULN * Hyperbilirubinemia secondary to tumor-associated extrahepatic biliary obstruction allowed * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for ≥ 4 weeks after the completion of study treatment * No history of autoimmune disease, including systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis * No uncontrolled medical problems * No active infections * No other cancer within the past 5 years except for superficial bladder cancer, nonmelanoma skin cancer, or low-grade prostate cancer not requiring therapy PRIOR CONCURRENT THERAPY: * More than 28 days since prior anticancer therapy * No prior cancer immunotherapy, including the same pancreatic cancer vaccine used in this study * More than 28 days since prior systemic steroid therapy or immunosuppressive therapy * No systemic steroid therapy or immunosuppressive therapy during and within 28 days after vaccine administration * No other concurrent immunotherapy, chemotherapy, radiotherapy, gene therapy, biologic therapy, or investigational therapy for the treatment of pancreatic cancer