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Treatment of Unresectable Hepatocellular Cancer With Opioid Growth Factor

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00706576
First Posted: June 27, 2008
Last Update Posted: August 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Penn State University
Information provided by (Responsible Party):
Eric Kimchi, University of Missouri-Columbia
  Purpose

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.


Condition Intervention Phase
Hepatocellular Cancer Drug: Infusion of opioid growth factor Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Unresectable Hepatocellular Cancer With Opioid Growth Factor: a Phase I Study

Resource links provided by NLM:


Further study details as provided by Eric Kimchi, University of Missouri-Columbia:

Primary Outcome Measures:
  • Number of participants with opioid growth factor toxicity [ Time Frame: Over the period of infusion and 1 hour after infusion ]
    primary outcome variable is toxicity and or tolerance to opioid growth factor in patients with hepatocellular cancer


Secondary Outcome Measures:
  • Change in plasma opioid growth factor levels [ Time Frame: During the infusion and 1 hour after infusion ]
    Study the biological kinetics and metabolism of opioid growth factor (OGF) by monitoring plasma OGF levels


Enrollment: 14
Actual Study Start Date: June 2008
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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)
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)
Other Names:
  • OGF
  • [Met5]-enkephalin

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • In this acute dose-finding section of the study, we will enroll patients with HCC and cirrhosis.
  • Both male and female patients 18 years of age or older will be eligible.
  • Patients with cancer must have a Karnofsky performance rating of at least 50%.
  • Patients must have HCC and cirrhosis that is not amenable to current therapies including liver resection, tumor ablation, or liver transplant.
  • Patients must be mentally alert and able to give informed consent.
  • Female patients who are menopausal, or of childbearing age who are surgically sterile or practicing birth control (chemical or mechanical) are eligible.
  • All females of childbearing potential must have a serum pregnancy test upon entry into the study and must take precautions to not become pregnant during the study (from the time of enrollment until 1 week after the infusion of OGF). No corticosteroid or narcotic therapy 24 hrs prior to infusion.
  • Volunteers must refrain from alcoholic beverages for 24 hours before, and 24 hours after, the day of infusion.
  • If patients have received sorafenib, at least 4 weeks must pass from the last dose.
  • At least four weeks must pass from significant surgery and the subject must be physically recovered.

Exclusion Criteria:

  • Patients with asthma, chronic obstructive pulmonary disease, unstable cardiovascular diseases (congestive heart failure, symptoms of coronary artery disease, cardiac arrhythmias, poorly controlled hypertension, have suffered a myocardial infarction in the preceding year or have an abnormal EKG) will not be allowed.
  • Patients with poorly controlled diabetes, seizure disorders, primary central nervous system (CNS) tumors or known brain metastases are excluded.
  • A clinical judgment will be made based on the other criteria and performance status as to the patient's ability to tolerate therapy.
  • Serum total bilirubin and international normalized ratio (INR) will be used as markers of liver function in the exclusion criteria as defined in Table 1 (see below).
  • Pregnant or nursing women are not eligible.
  • Patients requiring antibiotics in the preceding week for a serious infection are not eligible.
  • Volunteers may have on the morning of the study one 8 ounce glass of water or juice and toast.
  • EKG and laboratory tests will be reviewed to evaluate whether any exclusion criteria are met.
  • Those who are not eligible will be notified.

Table 1: Exclusion Criteria

  • Leukocyte Count < 3500/μl
  • Hemoglobin < 8500/μl
  • Blood urea nitrogen (BUN) > 30mg/dl (hydrated)
  • Creatinine > 2 mg/dl
  • Platlet Count < 55,000/mm3
  • INR (unless on coumadin) > 2
  • Total Bilirubin > 3.5mg/dl
  • Sodium < 130 mmol/L
  • Potassium <3.2 mmol/L
  • Glucose > 300 or < 60 mg/dl
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00706576


Locations
United States, Pennsylvania
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
University of Missouri-Columbia
Penn State University
Investigators
Principal Investigator: Eric T Kimchi, MD Penn State College of Medicine
  More Information

Responsible Party: Eric Kimchi, Associate Professor of Surgical Oncology, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00706576     History of Changes
Other Study ID Numbers: 26336
First Submitted: June 25, 2008
First Posted: June 27, 2008
Last Update Posted: August 2, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Eric Kimchi, University of Missouri-Columbia:
Hepatocellular cancer
HCC
Opioid growth factor
OGF
Cirrhosis

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Analgesics, Opioid
Mitogens
Enkephalin, Methionine
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents