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

Loyola University

Status and phase

Terminated

Phase 2

Conditions

Metastatic Pancreatic Cancer

Treatments

Drug: Ontak

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00726037

200732

Details and patient eligibility

About

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.

Full 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

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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