Treatment of Unresectable Hepatocellular Cancer With Opioid Growth Factor
Status:
Completed
Trial end date:
2013-07-01
Target enrollment:
Participant gender:
Summary
Hepatocellular cancer, one of the world's most deadly tumors, is associated with chronic
liver injury and cirrhosis. With the increasing occurrence of viral hepatitis, the incidence
of this cancer in the United States continues to rise. Surgical resection offers the only
hope for cure; but sadly, few patients are candidates for surgery due to their liver disease.
Liver transplant can be an effective treatment, but due to a scarcity of organs, most
patients do not qualify for this therapy either. Patients who are not candidates for these
procedures have very few therapeutic options as chemotherapy and radiation have little
efficacy. New therapies are desperately needed.
Opioid Growth Factor (OGF) inhibits the growth of a number of cancer lines in vitro by a
receptor-mediated mechanism. In pancreatic cancer this phenomenon has been well defined not
only in vitro but in animal models. Based upon these findings, a phase I trial has been
conducted demonstrating that OGF can be administered safely to patients with pancreatic
cancer. The investigators hypothesize that administration of OGF will inhibit the course of
cancer progression in human subjects with unresectable hepatocellular cancer and cirrhosis.
As a first step in testing this hypothesis, the investigators propose a phase I trial to
study the toxicity and pharmacokinetics of this therapy in patients suffering from inoperable
hepatocellular cancer and cirrhosis.
Phase:
Phase 1
Details
Lead Sponsor:
Penn State University University of Missouri-Columbia