NCT00982696

Treatment of Advanced Head and Neck Cancer

Treatment of Advanced Head and Neck Cancer With Opioid Growth Factors: Phase II

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate the efficacy of opioid growth factor (OGF) on tumor size and survival in patients with head and neck cancer who have failed standard therapy.

Detailed description

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 we 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. Apart from potentially having growth inhibitory action on cancer, OGF may have some psychological and other biological effects which may prove to be beneficial in the patient's treatment. Presently there is no effective therapy or quality of life adjuvants for the 30,000 Americans who develop head and neck cancer yearly.

Conditions

• Carcinoma, Squamous Cell of Head and Neck

Interventions

Type	Name	Description
BIOLOGICAL	Opioid Growth Factor	250ug per kilogram weekly IV infusions

Timeline

• Start date: 2008-02-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2009-09-23
• Last updated: 2014-09-30

Locations

1 site across 1 country: United States