Treatment of Advanced Head and Neck Cancer

Phase 2

Terminated

• Conditions: Carcinoma, Squamous Cell of Head and Neck
• Interventions: Biological: Opioid Growth Factor

• Registration Number: NCT00982696
• Lead Sponsor: Milton S. Hershey Medical Center

Brief 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.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2009-09-22
• Study First Submitted QC: 2009-09-22
• Study First Posted: 2009-09-23
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2014-09
• Disposition First Submitted: 2014-09-18
• Disposition First Submitted QC: 2014-09-18
• Last Update Submitted: 2014-09-18
• Disposition First Posted: 2014-09-30
• Last Update Posted: 2014-09-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• 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.
• Karnofsky performance rating of at lest 50%.

Exclusion Criteria

• 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.
• Pregnant or nursing women.
• Patients requiring antibiotics in the preceding 2 weeks for a serious infection are not eligible.
• Patients with a fever > 37.8 degrees C.
• Pulse < 60 or > 110
• Systolic blood pressure > 170 or less than 90 are not eligible.
• Patients with nasopharyngeal squamous cell carcinoma will be excluded
• Patients with hypercalcemia will be excluded from this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Opioid Growth Factor	Opioid Growth Factor (OGF)

Primary Outcome Measures

Name	Time	Method
Progression of tumor measured with CT scan	every 3 months

Secondary Outcome Measures

Name	Time	Method
Metastatic development using CT scan	every 3 months

Trial Locations

Locations (1)

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States