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.

Condition	Treatment or Intervention	Phase
stage IVA pancreatic cancer stage IVB pancreatic cancer recurrent pancreatic cancer adenocarcinoma of the pancreas	Drug: anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody  Procedure: antibody therapy  Procedure: biological response modifier therapy  Procedure: monoclonal antibody therapy	Phase II

Further Study Details: 

OBJECTIVES: Primary

• Determine clinical response (partial and complete responses) in patients with unresectable stage IV 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 presence of disease (locally advanced disease vs distant metastatic disease).

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.

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed pancreatic adenocarcinoma
• Stage IV 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)

Please refer to this study by ClinicalTrials.gov identifier  NCT00112580

Maryland
      Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda,  Maryland,  20892-1182,  United States; Recruiting

Study chairs or principal investigators

Richard E. Royal, MD,  Principal Investigator,  National Cancer Institute (NCI)   

Study ID Numbers:  CDR0000430666; NCI-05-C-0141; NCI-P6557; MDX-010-24; NCT00108888
Record last reviewed:  May 2005
Last Updated:  June 2, 2005
Record first received:  June 2, 2005
ClinicalTrials.gov Identifier:  NCT00112580
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-06-07