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

Inclusion Criteria:

- Histologically and cytologically confirmed diagnosis of squamous cell carcinoma

- Patients not amenable to curative treatments with further surgery and/or radiation

- Patients has failed treatment with chemotherapy

- Lesion must be distinct and the minimum measurements must be at least 2.0 cm x 2.0 cm
at baseline

- Patients must have a Karnofsky performance rating of at least 50%

Exclusion Criteria:

- Patients with severe and unstable cardiovascular diseases (congestive heart failure,
symptoms of coronary artery disease, cardiac arrhythmias, poorly controlled
hypertension, have suffered a myocardial infarction in the preceding year or have an
abnormal EKG)

- Treatment naïve subjects will not be included for study

- Patients with poorly controlled diabetes, seizure disorders, primary CNS tumors or
known brain metastases will be excluded from investigation

- 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°C

- pulse less than 60 or greater than 110

- systolic blood pressure > 170 or less than 90 are not eligible

- Patients with nasopharyngeal squamous cell carcinoma and patients with hypercalcemia
will be excluded

- Lab Values which warrant exclusion:

- Leukocyte Count < 3.5 K/UL

- Absolute Neutrophil Count < 1.5 K/UL

- Hemoglobin < 8.5 g/dl

- Blood Urea Nitrogen > 30 mg/dL (hydrated)

- Creatinine > 2.0 mg/dL

- Total Bilirubin > 4.0 mg/dL

- Platelet Count < 100,000 / mm 3

- Prothrombin Time > 2 sec over control

- INR (unless on coumarin) > 1.8

- Sodium < 130 mmol/L

- Potassium < 3.2 mmol/L

- Glucose > 300 and < 60 mg/dl

- Calcium > 10.2 mg/dL