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