MDX-010 in Treating Patients With Stage IV Pancreatic Cancer That Cannot Be Removed By Surgery

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed pancreatic adenocarcinoma
• •* Stage IV disease
• •* Locally (invasion of adjacent structures, including mesenteric arteries or organs) or distantly metastatic disease
• •* Unresectable disease
• •* Pancreatic adenocarcinoma with intraductal papillary mucinous neoplasm allowed
• •The following diagnoses are not allowed:
• •* Acinar cell carcinoma
• •* Pancreaticoblastoma
• •* Malignant cystic neoplasms
• •* Endocrine neoplasms
• •* Squamous cell carcinoma
• •* Vater and periampullary duodenal or common bile duct malignancies
• •Clinically evaluable disease with ≥ 1 site of measurable disease
• •Biliary or gastric outlet obstruction allowed provided it is effectively drained by endoscopic, operative, or interventional means
• •Pancreatic, biliary, or enteric fistulae allowed provided they are controlled with an appropriate drain
• •PATIENT CHARACTERISTICS:
• •Age
• •18 and over
• •Performance status
• •ECOG 0-2
• •Life expectancy
• •At least 3 months
• •Hematopoietic
• •WBC ≥ 2,500/mm\^3
• •Absolute neutrophil count ≥ 1,500/mm\^3
• •Platelet count ≥ 100,000/mm\^3
• •Hemoglobin ≥ 9 g/dL
• •Hematocrit ≥ 27%
• •Hepatic
• •Hepatitis B surface antigen negative
• •Hepatitis C virus antibody negative OR
• •Hepatitis C RNA negative by polymerase chain reaction
• •Renal
• •Creatinine \< 2.0 mg/dL
• •Immunologic
• •HIV negative
• •No history of or active autoimmune disease, including uveitis or autoimmune inflammatory eye disease
• •No active uncontrolled infection
• •Other
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix
• •No underlying medical condition that would preclude study participation
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010)
• •Chemotherapy
• •At least 3 weeks since prior chemotherapy for pancreatic adenocarcinoma and recovered
• •No concurrent chemotherapy
• •Endocrine therapy
• •More than 4 weeks since prior corticosteroids
• •No concurrent systemic or topical corticosteroids
• •Radiotherapy
• •At least 3 weeks since prior radiotherapy for pancreatic adenocarcinoma and recovered
• •Surgery
• •See Disease Characteristics
• •Other
• •At least 3 weeks since other prior therapy for pancreatic adenocarcinoma and recovered
• •No concurrent immunosuppressants (e.g., cyclosporin or its analog)