Treatment of Advanced Head and Neck Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2011-11-30

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.

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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.

Conditions

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Carcinoma, Squamous Cell of Head and Neck

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm

Opioid Growth Factor (OGF)

Group Type EXPERIMENTAL

Opioid Growth Factor

Intervention Type BIOLOGICAL

250ug per kilogram weekly IV infusions

Interventions

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Opioid Growth Factor

250ug per kilogram weekly IV infusions

Intervention Type BIOLOGICAL

Other Intervention Names

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endogenous opioid peptide Met-enkephalin

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No