Vaccine Treatment for Surgically Resected Pancreatic Cancer

Inclusion Criteria: A histological diagnosis of adenocarcinoma or other exocrine carcinoma of the pancreas. The patient's pathology must be reviewed and confirmed by Northwestern University's Pathology Department. AJCC Stage I or II Pancreatic carcinoma. Patients must have undergone surgical resection for the tumor. Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2. Serum albumin greater than or equal to 2.5 gm/dL. Expected survival greater than or equal to 6 months. Subjects must have a negative serology for Hep B, C and HIV prior to entering study. All On-Study Tests must be less than or equal to Grade I toxicity for patient to be eligible for study, excluding serum LDH levels. PT, PTT must be less than or equal to 1.5 x ULN except for patients who are on therapeutic anticoagulant therapy. Adequate organ function including: Marrow: hemoglobin greater than or equal to 10.0 gm/dL, absolute granulocyte count (AGC) greater than or equal to 1500/mm3, platelets greater than or equal to 100,000/mm3, absolute lymphocyte count greater than or equal to 475/mm3. Hepatic: serum total bilirubin less than or equal to 1.5 x ULN mg/dL, ALT (SGPT) and AST (SGOT) less than or equal to 2.5 x upper limit of normal (ULN). Renal: serum creatinine (sCr) less than or equal to 2.0 x ULN, or creatinine clearance (Ccr) greater than or equal to 30 mL/min. Prior therapy for pancreatic cancer that may include surgery and/or different neoadjuvant chemotherapy or adjuvant chemo-radiation regimens, or radiation therapy. Patients who undergo surgical resection and refuse chemotherapy or radiation therapy will be eligible. Patients must be greater than or equal to 4 weeks since surgery if treated with neoadjuvant therapy or greater than or equal to 4 weeks since conclusion of chemo-radiation if treated with post-operative adjuvant therapy and recovered from the toxicity of prior treatment to less than or equal to Grade I, exclusive of alopecia or fatigue. Patients must have the ability to understand the study, its inherent risks, side effects and potential benefits and be able give written informed consent to participate. Patients may not be consented by a durable power of attorney (DPA). All subjects of child producing potential must agree to use contraception or avoidance of pregnancy measures while enrolled on study and receiving the experimental product, and for one month after the last immunization. Exclusion Criteria: Age <18-years-old. Active metastases. Hypercalcemia > 2.9 mmol/L, unresponsive to standard therapy (e.g., I.V. hydration, diuretics, calcitonin or bisphosphonate therapy). Other malignancy within five years, unless the probability of recurrence of the prior malignancy is <5%. Patient's curatively treated for squamous and basal cell carcinoma of the skin or patients with a history of malignant tumor in the past that have been disease free for at least five years are also eligible for this study. History of organ transplant or current active immunosuppressive therapy (such as cyclosporine, tacrolimus, etc.). Subjects taking systemic corticosteroid therapy for any reason are not eligible. Subjects receiving inhaled or topical corticosteroids are eligible. Subjects who require systemic corticosteroids after beginning vaccination, will be removed from study. Significant or uncontrolled congestive heart failure (CHF), myocardial infarction or significant ventricular arrhythmias within the last six months. Active infection or antibiotics within 1-week prior to study, including unexplained fever (temp > 38.1C). Autoimmune disease (e.g., systemic lupus erythematosis (SLE), rheumatoid arthritis (RA), etc.). Patients with a remote history of asthma or mild active asthma are eligible. Other serious medical conditions that may be expected to limit life expectancy to less than 2 years (e.g., liver cirrhosis) or a serious illness in medical opinion of the clinical investigator. Any condition, psychiatric or otherwise, that would preclude informed consent, consistent follow-up or compliance with any aspect of the study (e.g., untreated schizophrenia or other significant cognitive impairment, etc.). A known allergy to any component of the alpha(1,3)galactosyltransferase tumor vaccine or cell lines. Prior splenectomy. Pregnant or nursing women due to the unknown effects of vaccination on the developing fetus or newborn infant. (For patients with child bearing potential, a βHCG must be completed within 7 days of first vaccination).