Gene Therapy in Treating Patients With Advanced Head and Neck Cancer
RATIONALE: Gene therapy may kill cancer cells by inhibiting a gene that promotes the development and growth of cancer.
PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who have advanced head and neck cancer.
|Head and Neck Cancer||Biological: EGFR antisense DNA Biological: growth factor antagonist therapy Drug: DC-cholesterol liposome||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Trial Of Intratumoral EGFR Antisense DNA And DC-Chol Liposomes In Advanced Oral Squamous Cell Carcinoma|
|Study Start Date:||March 1999|
|Study Completion Date:||March 2002|
|Primary Completion Date:||March 2002 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00009841
|United States, Pennsylvania|
|University of Pittsburgh Cancer Institute|
|Pittsburgh, Pennsylvania, United States, 15213-3489|
|Study Chair:||Jennifer R. Grandis, MD||University of Pittsburgh|