mdx-010 in treating patients with stage iv pancreatic cancer that cannot be removed by surgery

Conditions: 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.

objectives: primary * determine clinical response (partial and complete responses) in patients with unresectable stage iv (locally or distantly metastatic) pancreatic adenocarcinoma treated with anti-cytotoxic t-lymphocyte-associated antigen-4 monoclonal antibody (mdx-010). secondary * determine whether observed responses correlate with the incidence of autoimmunity in patients treated with this drug. outline: this is an open-label study. patients are stratified according to status of disease (locally vs distantly metastatic). patients receive anti-cytotoxic t-lymphocyte-associated antigen-4 monoclonal antibody (mdx-010) iv over 90 minutes on days 0, 21, 42, and 63. treatment repeats every 84 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. patients with disease progression after achieving a partial response or complete response receive 2 additional courses of therapy. after completion of study treatment, patients are followed at 3 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. projected accrual: a total of 42-82 patients (21-41 per stratum) will be accrued for this study within 2-4 years.

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)

Keywords: recurrent pancreatic cancer adenocarcinoma of the pancreas stage iv pancreatic cancer