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Original Article
July 2001

Clinical Experience With HLA-B7 Plasmid DNA/Lipid Complex in Advanced Squamous Cell Carcinoma of the Head and Neck

Author Affiliations

From the Departments of Otolaryngology–Head and Neck Surgery, University of Cincinnati, Cincinnati, Ohio (Drs Gleich and Gluckman), Baylor University/US Oncology Inc, Dallas, Tex (Dr Nemunaitis), University of Arkansas, Little Rock (Drs Suen and Hanna), University of Michigan, Ann Arbor (Dr Wolf), University of Washington, Seattle (Drs Coltrera and Villaret), University of California at Los Angeles (Dr Castro), University of Minnesota, Minneapolis (Dr Gapany), and University of Alabama, Birmingham (Dr Carroll); the Department of Medical Oncology and Therapeutics Research, City of Hope National Medical Center, Duarte, Calif (Dr Wagman); and Vical Inc, San Diego, Calif (Dr Gillespie and Ms Selk).

Arch Otolaryngol Head Neck Surg. 2001;127(7):775-779. doi:10-1001/pubs.Arch Otolaryngol. Head Neck Surg.-ISSN-0886-4470-127-7-ooa00174

Objective  To investigate the safety and efficacy of alloantigen plasmid DNA therapy in patients with advanced head and neck squamous cell carcinoma using Allovectin-7 (Vical Inc, San Diego, Calif), a DNA/lipid complex designed to express the class I major histocompatibility complex antigen HLA-B7.

Design  Multi-institutional prospective trial.

Setting  Academic medical setting.

Patients  A total of 69 patients were enrolled in 3 sequential clinical trials: a single-center phase 1 trial and 2 multicenter phase 2 trials. Eligibility criteria included unresectable squamous cell carcinoma that failed conventional therapy, Karnofsky performance status score of 70 or greater, and no concurrent anticancer or immunosuppressive therapies.

Intervention  Patients received 2 biweekly intratumoral injections of 10 µg (phase 1 and first phase 2 trials) or 100 µg (second phase 2 trial) of Allovectin-7 followed by 4 weeks of observation. Patients with stable or responding disease after the observation period were given a second treatment cycle identical to the first.

Main Outcome Measures  Patients were assessed for toxic effects, and tumor size was measured after cycles 1 (at 6 weeks) and 2 (at 16 weeks).

Results  Allovectin-7 treatment was well tolerated, with no grade 3 or 4 drug-related toxic effects. Of 69 patients treated, 23 (33%) had stable disease or a partial response after the first cycle of treatment and proceeded to the second cycle. After the second cycle, 6 patients had stable disease, 4 had a partial response, and 1 had a complete response. Responses persisted for 21 to 106 weeks.

Conclusions  Intratumoral plasmid DNA immunotherapy for head and neck cancer with Allovectin-7 is safe, and further investigations are planned in patients with less advanced disease, where it could potentially improve patient survival and reduce the need for radical high-morbidity treatments.