Status:
COMPLETED
MDX-010 in Treating Patients With Stage IV Pancreatic Cancer That Cannot Be Removed By Surgery
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
OBJECTIVES: Primary * Determine clinical response (partial and complete responses) in patients with unresectable stage IV (locally or distantly metastatic) pancreatic adenocarcinoma treated with ant...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
July 31 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2009
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00112580
Start Date
July 31 2005
End Date
June 30 2009
Last Update
September 27 2021
Active Locations (2)
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1
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182
2
NCI - Surgery Branch
Bethesda, Maryland, United States, 20892