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

August 23, 2016 updated by: Loyola University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola Univeristy Medical Center, Cardinal Bernardin Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Denileukin diftitox

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
days 8, 12 ,19,26 and 33 post administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
33 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loyola University

Collaborators

Eisai Inc.
Riveria Country Club Organization

Investigators

  • Principal Investigator: Margo Shoup, MD, Loyola University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

July 29, 2008

First Submitted That Met QC Criteria

July 30, 2008

First Posted (ESTIMATE)

July 31, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 29, 2016

Last Update Submitted That Met QC Criteria

August 23, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200732

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metastatic Pancreatic Cancer

Clinical Trials on Ontak

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe