Trial Information

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

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