Gene Therapy in Treating Patients With Advanced Head and Neck Cancer

OBJECTIVES: I. Determine the safety and biological activity of EGFR antisense DNA and
DC-chol liposomes in patients with advanced squamous cell carcinoma of the head and neck.
II. Determine the toxicity and maximum tolerated dose of this regimen in these patients.
III. Determine the antitumor response in patients treated with this regimen. IV. Determine
the effect of this regimen on EGFR expression levels, STAT protein expression/activation
levels, and apoptosis rates in biopsied tumor cells of these patients.

OUTLINE: This is a dose-escalation study. Patients receive EGFR antisense DNA and DC-chol
liposomes intratumorally weekly for 4 weeks. Courses repeat every 4 weeks for up to 6 months
in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients
receive escalating doses of EGFR antisense DNA and DC-chol liposomes until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 3 or 6 patients experience dose-limiting toxicity. Patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 20-36 patients will be accrued for this study.

DISEASE CHARACTERISTICS: Histologically confirmed advanced squamous cell carcinoma of the
head and neck Primary or recurrent disease Not amenable to standard therapy (surgery,
chemotherapy, or radiotherapy) Second primary lesions allowed Brain metastases allowed
after definitive radiotherapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 8 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT no greater than 4
times normal Renal: Creatinine no greater than 2 mg/dL Calcium no greater than 10.5 mg/dL
Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception (double-barrier method and oral contraception) prior to, during, and for at
least 2 weeks after study

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy
Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy
Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4
weeks since prior radiotherapy Surgery: See Disease Characteristics