Phase I Trial Of Intratumoral EGFR Antisense DNA And DC-Chol Liposomes In Advanced Oral Squamous Cell Carcinoma
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.
Primary Purpose: Treatment
Jennifer R. Grandis, MD
University of Pittsburgh
United States: Federal Government
|University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15213|