A Pilot Study, Evaluating the Efficacy of Regulatory T-cell Suppression by Ontak in Metastatic Pancreatic Cancer

Stopped early · Phase 2

Conditions studied: Metastatic Pancreatic Cancer

In brief

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 vaccine administration.

Key facts

Study ID

NCT00726037

Run by

Loyola University

People needed

7

Starts

2008-10-01

Expected to finish

2012-01-01

Last updated by the study team

2016-09-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Loyola Univeristy Medical Center, Cardinal Bernardin Cancer Center — Maywood, Illinois, United States

Full record on ClinicalTrials.gov

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