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

Arm | Intervention/treatment |
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Experimental: 1
Three doses of Ontak 9 mcg/Kg IV over 30 minutes every other day for 1 week
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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 |
- 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.
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, Illinois | |
Loyola Univeristy Medical Center, Cardinal Bernardin Cancer Center | |
Maywood, Illinois, United States, 60153 |
Principal Investigator: | Margo Shoup, MD | Loyola University |
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 |
Denileukin diftitox Metastatic Pancreatic Cancer Ontak Regulatory T-cell |
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms |
Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Denileukin diftitox Antineoplastic Agents |