A Randomized Phase II Study of TNFerade Biologic with 5-FU and Radiation Therapy for First-Line Treatment of Unresectable Locally Advanced Pancreatic Cancer

Study Summary

The purpose of this study is to determine whether a new, experimental medication (not approved by the Food and Drug Administration) TNFerade biologic, when given in combination with standard 5-FU chemotherapy, and radiation therapy is effective and safe in treating patients with locally advanced pancreatic cancer. Participants will receive TNFerade biologic by endoscopic ultrasound injections directly into their tumor weekly for 6 weeks. Patients will receive radiation to their tumor five days a week for 28 days. 5-FU will be given intravenously by a continuous infusion for five days every week during radiation. Patients will be monitored for response with CT scans (a special type of X-ray that can produce detailed pictures of structures inside the body), and weekly blood tests will be obtained to monitor for the side effects of chemotherapy.

Participation Details

• Adults over age 18
• Must have pancreatic cancer that is not removable with surgery
• Must have pancreatic cancer that has not spread to other organs
• Must not have received prior chemotherapy or radiation therapy
• Must have normal kidney, liver, and blood function

Study Director: Mitchell Posner, MD
Department: Surgery

For more information, contact:

Rose Arrieta, RN
5841 S. Maryland Ave., MC 7114
Chicago, IL 60637
(773) 834-7964

IRB: #11741B