Treatment of Advanced Head and Neck Cancer

What Was Tested

The trial (phase 2) is built around Met-Enkephalin (Opioid Growth Factor).

It had 1 arm (groups): Single Arm (experimental).

Opioid Growth Factor (OGF).

The registry classes the interventions as biological.

More on the Plan

The major focus of the study will involve assessment of tumor response, patient survival, tolerance to drug, quality of life, depression, pain management and nutrition.

During the study the researchers will begin to study the kinetics of opioid growth factor (OGF) exogenous administration and the relationship between plasma OGF levels, stage of disease and length of treatment.

Who Took Part

The registry lists 5 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: Histologically and cytologically confirmed diagnosis of squamous cell carcinoma. Patients not amenable to curative treatments with further surgery and/or radiation. Patient has failed treatment with chemotherapy. Lesions must be distinct and the minimum measurements must be at least 2.0 cm x 2.0 cm at baseline.

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: patients with severe and unstable cardiovascular disease; treatment naive subjects will not be included for study; patients with poorly controlled diabetes, seizure disorder, primary cns tumors or known brain metastases will be excluded.

How the Study Was Run

It was run as a single-group and open-label study.

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 2008-02 with completion listed for 2011-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Progression of tumor measured with CT scan (time frame: every 3 months).

It also tracked 1 secondary outcome, for example Metastatic development using CT scan.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Met-Enkephalin (Opioid Growth Factor) in 5 people.

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

It ended early (terminated); 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.