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

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ClinicalTrials.gov Identifier: NCT00726037
Recruitment Status : Terminated (Collaborator withdrew support due to a drug supply interruption.)
First Posted : July 31, 2008
Results First Posted : August 24, 2016
Last Update Posted : September 29, 2016
Sponsor:
Collaborators:
Riveria Country Club Organization
Eisai Inc.
Information provided by (Responsible Party):
Loyola University

Study Description
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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 vaccine administration.

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Cancer Drug: Ontak Phase 2

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2008
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. T-reg Suppression From a Fractionated Dose of Ontak in Patients With Metastatic Pancreatic Cancer [ Time Frame: days 8, 12 ,19,26 and 33 post administration ]
    The duration of T reg suppression from a fractionated dose of Ontak in patients will be measured in patients with metastatic pancreatic cancer.


Secondary Outcome Measures :
  1. Optimal Time for Future Dendritic Cell Vaccine Administration [ Time Frame: 33 Days ]
    The goal is to define the optimal time with 95% sensitivity and 95% specificity for future dendritic cell vaccine administration


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00726037


Locations
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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
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Principal Investigator: Margo Shoup, MD Loyola University
More Information
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Publications:

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Responsible Party: Loyola University
ClinicalTrials.gov Identifier: NCT00726037    
Other Study ID Numbers: 200732
First Posted: July 31, 2008    Key Record Dates
Results First Posted: August 24, 2016
Last Update Posted: September 29, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Loyola University:
Denileukin diftitox
Metastatic Pancreatic Cancer
Ontak
Regulatory T-cell
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
 Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Denileukin diftitox
Antineoplastic Agents