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NCT00706576 · ClinicalTrials.gov registry record · Phase 1
Treatment of Unresectable Hepatocellular Cancer With Opioid Growth Factor
A Phase 1 study, sponsored by University of Missouri-Columbia.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT00706576 is a Phase 1 study that has completed, run by University of Missouri-Columbia. The registered enrollment target is 14 participants.
The verdict
NCT00706576, a Phase 1 study, has completed, sponsored by University of Missouri-Columbia.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
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.
Interventions
- DRUG Infusion of opioid growth factor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2008-06 |
| Est. Completion | 2013-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00706576
The ClinicalTrials.gov registry entry for NCT00706576 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Missouri-Columbia, which has 291 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Infusion of opioid growth factor is the first listed.
NCT00706576 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00706576 about?
NCT00706576 is a clinical study titled "Treatment of Unresectable Hepatocellular Cancer With Opioid Growth Factor". 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, fe...
What is the current status of trial NCT00706576?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2008-06. Estimated completion is 2013-07.
What interventions are being tested in trial NCT00706576?
The interventions under investigation include: Infusion of opioid growth factor (DRUG).
Who is sponsoring clinical trial NCT00706576?
This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.
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