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Treatment of Unresectable Hepatocellular Cancer With Opioid Growth Factor

NCT00706576 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2017-08-02

No results posted yet for this study

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.

Conditions

  • Hepatocellular Cancer

Interventions

DRUG

Infusion of opioid growth factor

Volunteers will be treated with an intravenous infusion of opioid growth factor(OGF) starting at 100 µg/kg with a 50 µg/kg dose escalation with each succeeding group. The investigational drug, OGF, will be diluted in sterile saline to its appropriate concentration based upon the body weight of the volunteer and administered in a volume of 60 ml over 45 minutes (rate of 2 ml/min)

Sponsors & Collaborators

  • Penn State University

    collaborator OTHER

  • University of Missouri-Columbia

    lead OTHER

Principal Investigators

  • Eric T Kimchi, MD · Penn State College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00706576 on ClinicalTrials.gov