Status:
TERMINATED
A Pilot Study, Evaluating the Efficacy of Regulatory T-cell Suppression by Ontak in Metastatic Pancreatic Cancer
Lead Sponsor:
Loyola University
Collaborating Sponsors:
Riveria Country Club Organization
Eisai Inc.
Conditions:
Metastatic Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is designed to determine the duration of T reg suppression in patients with metastatic pancreatic cancer receiving Ontak. The goal is to define the optimal time for future dendritic cell va...
Detailed Description
Despite improved insight into the epidemiology and biology, pancreatic cancer remains a significant health problem as evidenced by the disappointing survival rates associated with advanced disease. Be...
Eligibility Criteria
Inclusion
- Male patients and nonpregnant, nonlactating female patient \> 18 years old
- Histologic diagnosis of pancreatic cancer with distant disease seen on CT or MRI with no prior chemotherapy or radiotherapy for a least 4 weeks
- Karnofsky performance status equal to or greater than 70%
- Life expectancy of at least 3 months.
- No uncontrolled pain
- No symptoms of bowel obstruction
- Women with child bearing potential must agree to use adequate contraceptives. If she should become pregnant she needs to inform the treating physician
- Ability to give informed consent
Exclusion
- Positive serologic testing for HIV, AIDS, human T-cell lymphotrophic virus type 1, hepatitis B, or hepatitis C.
- Hemoglobin \<9g/dL; hematocrit \<27%; platelets \<100,000/ U/L without transfusion support
- Creatinine \> 1.8 mg/dL
- Serum albumin \< 2.0 mg/dL
- AST \> 3X ULN; ALT \> 3X ULN
- Bilirubin \> 1.8
- Uncontrolled angina, arrhythmias, bronchospasm, hypertension, or hypercalcemia.
- Corticosteroid use within 28 days
- Chemotherapy or radiation within 28 days
- Bacteremia or other signs of active systemic infection
- History of autoimmune disease
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00726037
Start Date
October 1 2008
End Date
January 1 2012
Last Update
September 29 2016
Active Locations (1)
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1
Loyola Univeristy Medical Center, Cardinal Bernardin Cancer Center
Maywood, Illinois, United States, 60153