Treatment of Unresectable Hepatocellular Cancer With Opioid Growth Factor

What Was Tested

The trial (phase 1) is built around Met-Enkephalin (Opioid Growth Factor).

It had 1 arm (groups): Infusion of opioid growth factor (experimental).

The registry classes the interventions as drug.

More on the Plan

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 cirrhosis predisposes to the development of this malignancy.

Unfortunately, due to associated liver disease and stage of tumor progression at the time of diagnosis, very few patients are candidates for surgical therapy.

Who Took Part

14 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Both male and female patients 18 years of age or older will be eligible. 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. Volunteers must refrain from alcoholic beverages for 24 hours before, and 24 hours after, the day of infusion.

The full record lists 10 inclusion and 19 exclusion criteria; among the exclusions: 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; pregnant or nursing women are not eligible.

How the Study Was Run

The set-up was single-group and open-label.

Everyone knew when Met-Enkephalin (Opioid Growth Factor) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2008-06 with completion listed for 2013-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of participants with opioid growth factor toxicity (time frame: Over the period of infusion and 1 hour after infusion).

It also tracked 1 secondary outcome, for example Change in plasma opioid growth factor levels.

What This Means in Plain Language

Put simply, this is a phase 1 trial of Met-Enkephalin (Opioid Growth Factor) in 14 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Met-Enkephalin (Opioid Growth Factor) compound page, all human trials.