Treatment of Advanced Head and Neck Cancer With Opioid Growth Factor

The investigators' research group has been studying the mechanisms concerning the origins
and course of head and neck squamous cell carcinoma (HNSCC) with the long-range goal of
designing strategies for early diagnosis and treatment. Preclinical studies have found that
the endogenous (native) opioid peptide [Met5]-enkephalin, termed opioid growth factor (OGF),
and its receptor (OGFr) form a tonically active growth inhibitory system that targets cell
replication in HNSCC.

The objective of this particular application, which is the next step toward attainment of
our long-range goal, is to determine the efficacy of OGF in the treatment of head and neck
squamous cell carcinoma. The central hypothesis for the proposed research is that cell
proliferation in HNSCC is dependent on the OGF-OGFr axis. The rationale for the proposed
investigations is that exogenous administration of OGF to patients with advanced HNSCC will
extend survival and improve quality of life by depressing cell replicative events.

Aim #1. Treatment of HNSCC patients with OGF infusions and monitoring of tumor progression
and survival.

Aim #2. Evaluate the quality of life of HNSCC patients receiving OGF.

Aim #3. Establish the pharmacokinetics of OGF in plasma of HNSCC patients receiving this
peptide.