| Inclusion Criteria: | 1) Patient must have a confirmed diagnosis of squamous cell carcinoma of the head and neck.
2) Primary sites include only those regions within oral cavity, oropharynx, larynx, hypopharynx, and paranasal sinus.
3) Primary lesions must have been stage III or stage IV (American Joint Committee on Cancer, 1988).
4) Patients must: 1) be completely resected of disease, or 2) have had radiotherapy alone, or 3) have had surgery plus postoperative radiotherapy. They should be entered within 3 to 24 weeks of surgery and/or definitive radiotherapy.
5) Patients may have received chemotherapy, immunotherapy or hormonal therapy prior to entry into the study and must have recovered from acute toxic effects of surgery or radiotherapy.
6) Patients must have a Karnofsky performance status >= 60 percent (<= 2 by Zubrod scale) (see Appendix B).
7) Patients must have adequate hematologic parameters (WBC >= 3,000; platelets >= 100,000), adequate renal function (creatinine <= 1.5 mg%), and adequate liver function (total bilirubin <= 1.5 mg%; SGPT <= 56U/ml).
8) Patients must be >= 18 years of age.
9) Patients must sign informed consent form indicating awareness of the investigational nature of the study.
10) Patients must have fasting serum triglyceride level <= 2 x upper limits of normal. |