Treatment of Advanced Head and Neck Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Carcinoma, Squamous Cell of Head and Neck

Intervention / Treatment
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* Biological: Opioid Growth Factor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>Opioid Growth Factor (OGF) | Biological: Opioid Growth Factor<br>* 250ug per kilogram weekly IV infusions<br>* Other names: Met-enkephalin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of tumor measured with CT scan |  | every 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metastatic development using CT scan |  | every 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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head and neck cancer, opioid growth factor