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

This study has been terminated.
(Manufacturer of Ontak withdrew support for the study due to drug supply interruption.)
Sponsor:
Collaborators:
Riveria Country Club Organization
Eisai Inc.
Information provided by (Responsible Party):
Loyola University
ClinicalTrials.gov Identifier:
NCT00726037
First received: July 29, 2008
Last updated: October 29, 2012
Last verified: October 2012
History of Changes
  Purpose

This study is designed to determine the following:

  1. 1. The degree and 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
  2. 2. To determine the safety of anti-CD4/CD25 monoclonal antibody (Ontak) in patients with metastatic pancreatic cancer
  3. 3. To follow patients treated with Ontak for a clinical response as determined by Ca 19-9 and CT scans

Condition Intervention Phase
Metastatic Pancreatic Cancer
 Drug: Ontak
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study Evaluating the Efficacy of Regulatory T-cell (T-reg) Suppression by Denileukin Diftitox (Ontak) in Metastatic Pancreatic Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Loyola University:

Primary Outcome Measures:
  • 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 [ Time Frame: days 8, 12 ,19,26 and 33 post administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the safety of a single dose of anti-CD4/CD25 monoclonal antibody Ontak) in patients with metastatic pancreatic cancer [ Time Frame: lifetime ] [ Designated as safety issue: Yes ]

Enrollment: 7
Study Start Date: October 2008
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Three doses of Ontak 9 mcg/Kg IV over 30 minutes every other day for 1 week
 Drug: Ontak
One dose of Ontak 9 mcg/Kg IV over 30 minutes times 3 doses. 1 dose every other day
Other Name: Denileukin diftitox

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. 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00726037

Locations
United States, Illinois
Loyola Univeristy Medical Center, Cardinal Bernardin Cancer Center
Maywood, Illinois, United States, 60153
Sponsors and Collaborators
Loyola University
Riveria Country Club Organization
Eisai Inc.
Investigators
Principal Investigator: Margo Shoup, MD Loyola University
  More Information

No publications provided

Responsible Party: Loyola University
ClinicalTrials.gov Identifier: NCT00726037     History of Changes
Other Study ID Numbers: 200732
Study First Received: July 29, 2008
Last Updated: October 29, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Loyola University:
Denileukin diftitox
Metastatic Pancreatic Cancer
Ontak
Regulatory T-cell

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Denileukin diftitox
Interleukin-2
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 17, 2013