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Clinical Experience With HLA-B7 Plasmid DNA/Lipid Complex in Advanced Squamous Cell Carcinoma of the Head and Neck
Lyon L. Gleich, MD;
Jack L. Gluckman, MD;
John Nemunaitis, MD;
James Y. Suen, MD;
Ehab Hanna, MD;
Gregory T. Wolf, MD;
Marc D. Coltrera, MD;
Douglas B. Villaret, MD;
Lawrence Wagman, MD;
Dan Castro, MD, PhD;
Markus Gapany, MD;
William Carroll, MD;
Deirdre Gillespie, MD;
Linda M. Selk, BA
Arch Otolaryngol Head Neck Surg. 2001;127:775-779.
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.
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).
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