Clinical trial · Interventional
A Pilot Study, Evaluating the Efficacy of Regulatory T-cell Suppression by Ontak in Metastatic Pancreatic Cancer
A Pilot Study Evaluating the Efficacy of Regulatory T-cell (T-reg) Suppression by Denileukin Diftitox (Ontak) in Metastatic Pancreatic Cancer
NCT00726037CI-TRIAL-00024076terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Collaborator withdrew support due to a drug supply interruption.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ontak | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Three doses of Ontak 9 mcg/Kg IV over 30 minutes every other day for 1 week
- interventionNames
- Drug: Ontak
Primary outcomes (1)
- measure
- T-reg Suppression From a Fractionated Dose of Ontak in Patients With Metastatic Pancreatic Cancer
- timeFrame
- days 8, 12 ,19,26 and 33 post administration
- description
- The duration of T reg suppression from a fractionated dose of Ontak in patients will be measured in patients with metastatic pancreatic cancer.
Secondary outcomes (1)
- measure
- Optimal Time for Future Dendritic Cell Vaccine Administration
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (15)
- BACKGROUNDConlon KC, Klimstra DS, Brennan MF. Long-term survival after curative resection for pancreatic ductal adenocarcinoma. Clinicopathologic analysis of 5-year survivors. Ann Surg. 1996 Mar;223(3):273-9. doi: 10.1097/00000658-199603000-00007. PMID 8604907
- BACKGROUNDSperti C, Pasquali C, Piccoli A, Pedrazzoli S. Survival after resection for ductal adenocarcinoma of the pancreas. Br J Surg. 1996 May;83(5):625-31. doi: 10.1002/bjs.1800830512. PMID 8689203
- BACKGROUNDWarshaw AL, Fernandez-del Castillo C. Pancreatic carcinoma. N Engl J Med. 1992 Feb 13;326(7):455-65. doi: 10.1056/NEJM199202133260706. No abstract available. PMID 1732772
- BACKGROUNDZwar TD, van Driel IR, Gleeson PA. Guarding the immune system: suppression of autoimmunity by CD4+CD25+ immunoregulatory T cells. Immunol Cell Biol. 2006 Dec;84(6):487-501. doi: 10.1111/j.1440-1711.2006.01471.x. Epub 2006 Sep 5. PMID 16956386
- BACKGROUNDKnutson KL, Disis ML, Salazar LG. CD4 regulatory T cells in human cancer pathogenesis. Cancer Immunol Immunother. 2007 Mar;56(3):271-85. doi: 10.1007/s00262-006-0194-y. Epub 2006 Jul 4. PMID 16819631
- BACKGROUNDCuriel TJ, Coukos G, Zou L, Alvarez X, Cheng P, Mottram P, Evdemon-Hogan M, Conejo-Garcia JR, Zhang L, Burow M, Zhu Y, Wei S, Kryczek I, Daniel B, Gordon A, Myers L, Lackner A, Disis ML, Knutson KL, Chen L, Zou W. Specific recruitment of regulatory T cells in ovarian carcinoma fosters immune privilege and predicts reduced survival. Nat Med. 2004 Sep;10(9):942-9. doi: 10.1038/nm1093. Epub 2004 Aug 22. PMID 15322536
- BACKGROUNDWoo EY, Yeh H, Chu CS, Schlienger K, Carroll RG, Riley JL, Kaiser LR, June CH. Cutting edge: Regulatory T cells from lung cancer patients directly inhibit autologous T cell proliferation. J Immunol. 2002 May 1;168(9):4272-6. doi: 10.4049/jimmunol.168.9.4272.