Vaccine Therapy Combined With Adjuvant Chemoradiotherapy in Treating Patients With Resected Stage I or Stage II Adenocarcinoma (Cancer) of the Pancreas
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage I pancreatic cancer, stage II pancreatic cancer, duct cell adenocarcinoma 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
Sites / Locations
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Arms of the Study
Arm 1
Experimental
GVAX pancreatic cancer vaccine
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