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A Pilot Study Evaluating the Efficacy of Regulatory T-cell (T-reg) Suppression by Denileukin Diftitox (Ontak) in Metastatic Pancreatic Cancer

Phase 2
18 Years
Not Enrolling
Metastatic Pancreatic Cancer

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Trial Information

A Pilot Study Evaluating the Efficacy of Regulatory T-cell (T-reg) Suppression by Denileukin Diftitox (Ontak) in Metastatic Pancreatic Cancer

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. Because of its aggressive growth and early metastatic dissemination, only
20% of patients can be treated by surgery at the time of diagnosis. Furthermore, the
overall 5-year survival rate of stage IV disease is < 5% [1-3] despite chemotherapy. With
such a dismal outlook, it is obvious that novel treatment strategies are required.

There is limited experience in the literature with the use of Ontak in the treatment of
metastatic pancreatic cancer. Viehl, et al, demonstrated in a murine model of pancreatic
cancer, that ontak combined with whole tumor vaccine led to a significantly increased T
cell-dependent antitumor immune response, as well as an improved survival compared to
controls. Our group has an active trial at Loyola evaluating the role of dendritic cell
vaccine in patients with unresectable, not metastatic, pancreatic cancer. Preliminary data
suggests a correlation with time to progression and restoration of Tregs following an
initial decrease after the DC injection. The goal of the current proposal is to determine
the time point at which the Tregs reach the nadir within four weeks of ontak injection. When
this is determined, we will eventually propose administering ontak followed by DC vaccine at
the nadir Treg time point for patients with unresectable pancreatic cancer

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

1. To determine the degree and duration of T reg suppression from a fractionated dose of Ontak in patients with metastatic pancreatic cancer, with the goal to define the optimal time for future dendritic cell vaccine administration

Outcome Time Frame:

days 8, 12 ,19,26 and 33 post administration

Safety Issue:


Principal Investigator

Margo Shoup, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Loyola University


United States: Food and Drug Administration

Study ID:




Start Date:

October 2008

Completion Date:

January 2012

Related Keywords:

  • Metastatic Pancreatic Cancer
  • Denileukin diftitox
  • Metastatic Pancreatic Cancer
  • Ontak
  • Regulatory T-cell
  • Pancreatic Neoplasms



Loyola Univeristy Medical Center, Cardinal Bernardin Cancer Center Maywood, Illinois  60153