A Safety and Efficacy Trial of Lethally Irradiated Allogeneic Pancreatic Tumor Cells Transfected With the GM-CSF Gene in Combination With Adjuvant Chemoradiotherapy for the Treatment of Adenocarcinoma of the Pancreas

Date de début de l'étude : 1 janvier 2002

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