Vaccine Therapy With or Without Cyclophosphamide in Treating Patients Undergoing Chemotherapy and Radiation Therapy for Stage I or Stage II Pancreatic Cancer That Can Be Removed by Surgery
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: GVAX pancreatic cancer vaccine; cyclophosphamide
Intervention description: Given intradermally; Given IV (Arm B), given orally (Arm C)
Intervention MeSH terms: Cyclophosphamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the pancreas; stage I pancreatic cancer; stage II pancreatic cancer

Summary:

      RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an effective
      immune response to kill pancreatic cancer cells. Drugs used in chemotherapy, such as
      cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing
      the cells or by stopping them from dividing. Giving vaccine therapy together with
      cyclophosphamide may kill more tumor cells. It is not yet known whether vaccine therapy is
      more effective with or without cyclophosphamide in treating patients with pancreatic cancer.

      PURPOSE: This randomized clinical trial is studying the side effects of vaccine therapy and
      to see how well it works when given with or without cyclophosphamide in treating patients
      undergoing chemotherapy and radiation therapy for stage I or stage II pancreatic cancer that
      can be removed by surgery.
    

Eligibility criteria:

        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