Vaccine Therapy Combined With Adjuvant Chemoradiotherapy in Treating Patients With Resected Stage I or Stage II Adenocarcinoma (Cancer) of the Pancreas
Condition: Pancreatic Cancer
MeSH terms: Adenocarcinoma; Pancreatic Neoplasms
Intervention: GVAX pancreatic cancer vaccine
Intervention description: Patients will receive vaccinations consisting of 5E8 vaccine cells. The first vaccination is administered 6-8 weeks after surgery. Four to eight weeks following the completion of the last cycle of adjuvant radiation and chemotherapy (chemo-radiation therapy is standard of care and not part of the protocol) eligible patients will receive three additional vaccinations at one month intervals. Patients who continue to remain disease-free will receive a fifth "booster" vaccination, six months following the fourth vaccination.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage I pancreatic cancer; stage II pancreatic cancer; duct cell adenocarcinoma of the pancreas

Summary:

      RATIONALE: Vaccines made from gene-modified pancreatic cancer cells may make the body build
      an immune response to kill tumor cells. Drugs used in chemotherapy, such as fluorouracil,
      work in different ways to stop tumor cells from dividing so they stop growing or die.
      Radiation therapy uses high-energy x-rays to damage tumor cells. Giving vaccine therapy
      together with chemotherapy and radiation therapy after surgery may kill any remaining tumor
      cells.

      PURPOSE: This phase II trial is studying how well giving vaccine therapy together with
      adjuvant chemoradiotherapy works in treating patients with resected stage I or stage II
      adenocarcinoma (cancer) of the pancreas.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed invasive ductal adenocarcinoma of the head, neck, and
             uncinate process of the pancreas

               -  Mixed adenocarcinoma tumors allowed if the predominant invasive component of the
                  tumor is adenocarcinoma

               -  Stage I or II (clinical stage T1-3, N0-1, M0) disease

          -  Has undergone pancreaticoduodenectomy at the Johns Hopkins Hospital within the past
             8-10 weeks

               -  Completely resected (R0) or microscopic residual (R1) disease

          -  No diagnosis other than ductal adenocarcinoma, including any of the following:

               -  Adenosquamous

               -  Squamous cell

               -  Colloid

               -  Islet cell

               -  Non-invasive intraductal papillary mucinous neoplasms

               -  Serous or mucinous cystadenoma or cystadenocarcinoma

               -  Carcinoid

               -  Small or large cell carcinoma

               -  Intraductal oncocytic papillary neoplasms

               -  Osteoclast-like giant cell tumors

               -  Acinar cell carcinoma

               -  Pancreatoblastoma

               -  Solid pseudopapillary tumors

               -  Undifferentiated small cell carcinoma

               -  Non-epithelial tumors (sarcoma, gastrointestinal stromal tumor, or lymphoma)

               -  Adenocarcinoma of the ampulla

               -  Adenocarcinoma of the distal bile duct

               -  Adenocarcinoma of the duodenum

          -  No recurrent disease

          -  No metastatic disease, including peritoneal implants or liver and/or lung involvement

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  ECOG 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count >/= 1,500/mm^3

          -  Platelet count >/= 100,000/mm^3

          -  Hemoglobin >/= 10 g/dL

        Hepatic

          -  Bilirubin </= 2 mg/dL

          -  AST/ALT </= 2 times upper limit of normal (ULN)

          -  Alkaline phosphatase </= 5 times ULN

        Renal

          -  Creatinine </= 2 mg/dL

        Pulmonary

          -  No asthma or chronic obstructive pulmonary disease requiring systemic corticosteroids

        Immunologic

          -  HIV negative

          -  No active infection

          -  No prior or concurrent autoimmune disease requiring treatment with systemic
             immunosuppressants, including any of the following:

               -  Inflammatory bowel disease

               -  Systemic vasculitis

               -  Scleroderma

               -  Psoriasis

               -  Multiple sclerosis

               -  Hemolytic anemia or immune thrombocytopenia

               -  Rheumatoid arthritis

               -  Systemic lupus erythematosus

               -  Sjogren's syndrome

               -  Sarcoidosis

          -  Negative results to viral delayed-type hypersensitivity serology testing if autologous
             tumor cells are available

        Other

          -  No postoperative complications (e.g., inability to take oral nutrition >/= 1,500
             calories/day, ongoing requirement for long-term biliary stenting, or persistence of
             wound infection)

          -  No other malignancy within the past 5 years except nonmelanoma skin cancer

          -  No uncontrolled medical conditions that would preclude study participation

          -  No other major active medical or psychosocial problem that could be exacerbated by
             study treatment

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for at least 4 weeks
             after study participation

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  More than 1 month since prior biologic therapy

          -  No other concurrent biologic therapy, immunotherapy, or gene therapy for pancreatic
             cancer

        Chemotherapy

          -  More than 1 month since prior chemotherapy

          -  No other concurrent chemotherapy for pancreatic cancer

        Endocrine therapy

          -  More than 28 days since prior systemic steroids

          -  No concurrent systemic corticosteroids

        Radiotherapy

          -  More than 1 month since prior radiotherapy

          -  No other concurrent radiotherapy for pancreatic cancer

        Surgery

          -  See Disease Characteristics

          -  Recovered from prior surgery

        Other

          -  More than 1 month since prior participation in an investigational new drug trial

          -  No other concurrent investigational therapy for pancreatic cancer