Status:
COMPLETED
Treatment of Unresectable Hepatocellular Cancer With Opioid Growth Factor
Lead Sponsor:
University of Missouri-Columbia
Collaborating Sponsors:
Penn State University
Conditions:
Hepatocellular Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
Detailed Description
STUDY OBJECTIVES Hepatocellular cancer (HCC) is one of the most prevalent cancers in the world. About 19,160 new cases are anticipated to occur in the US in 2007. Any form of chronic liver injury and ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00706576
Start Date
June 1 2008
End Date
July 1 2013
Last Update
August 2 2017
Active Locations (1)
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1
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033