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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

Tracking Information
First Submitted Date  ICMJE July 29, 2008
First Posted Date  ICMJE July 31, 2008
Results First Submitted Date  ICMJE April 26, 2013
Results First Posted Date  ICMJE August 24, 2016
Last Update Posted Date September 29, 2016
Study Start Date  ICMJE October 2008
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 30, 2008)
1. To determine the degree and duration of T reg suppression of a single 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 4, 8 15 ,22 and 29 post administration ]
Change History Complete list of historical versions of study NCT00726037 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2016)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2008)
To determine the safety of a single dose of anti-CD4/CD25 monoclonal antibody Ontak) in patients with metastatic pancreatic cancer [ Time Frame: lifetime ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study, Evaluating the Efficacy of Regulatory T-cell Suppression by Ontak in Metastatic Pancreatic Cancer
Official Title  ICMJE A Pilot Study Evaluating the Efficacy of Regulatory T-cell (T-reg) Suppression by Denileukin Diftitox (Ontak) in Metastatic Pancreatic Cancer
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Pancreatic Cancer
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: 1
Three doses of Ontak 9 mcg/Kg IV over 30 minutes every other day for 1 week
Intervention: Drug: Ontak
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 29, 2012)
7
Original Estimated Enrollment  ICMJE
 (submitted: July 30, 2008)
10
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00726037
Other Study ID Numbers  ICMJE 200732
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Loyola University
Study Sponsor  ICMJE Loyola University
Collaborators  ICMJE
  • Riveria Country Club Organization
  • Eisai Inc.
Investigators  ICMJE
Principal Investigator: Margo Shoup, MD Loyola University
PRS Account Loyola University
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP