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

• Status: Terminated
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

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 vaccine administration.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Loyola University
• Collaborators: Eisai Inc.; Riveria Country Club Organization
• Treatments: Denileukin diftitox; Interleukin-2

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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