MDX-010 in Treating Patients With Stage IV Pancreatic Cancer That Cannot Be Removed By Surgery
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: ipilimumab
Intervention MeSH terms: Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent pancreatic cancer; adenocarcinoma of the pancreas; stage IV pancreatic cancer

Summary:

      RATIONALE: Biological therapies, such as MDX-010, may stimulate the immune system in
      different ways and stop tumor cells from growing.

      PURPOSE: This phase II trial is studying how well MDX-010 works in treating patients with
      stage IV pancreatic cancer that cannot be removed by surgery.
    

Eligibility 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)