OBJECTIVE: To investigate the safety and efficacy of @entity22140 plasmid DNA therapy in @entity1 with advanced head and @entity213 using Allovectin-7 (Vical Inc, San Diego, @entity2948 ), 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. @entity1 : A total of 69 @entity1 were enrolled in 3 sequential clinical trials: a single-center phase 1 trial and 2 multicenter phase 2 trials. Eligibility criteria included unresectable @entity957 that failed conventional therapy, Karnofsky performance status score of 70 or greater, and no concurrent anticancer or immunosuppressive therapies. INTERVENTION: @entity1 received 2 biweekly intratumoral injections of 10 microg (phase 1 and first phase 2 trials) or 100 microg (second phase 2 trial) of Allovectin-7 followed by 4 weeks of observation. @entity1 with stable or responding disease after the observation period were given a second treatment cycle identical to the first. MAIN OUTCOME MEASURES: @entity1 were assessed for toxic effects, and @entity5 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 @entity1 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 @entity1 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 @entity135 with Allovectin-7 is safe, and further investigations are planned in @entity1 with @entity1442 , where it could potentially improve @entity1 survival and reduce the need for radical high-morbidity treatments.

Clinical experience with HLA-B7 plasmid DNA/lipid complex in advanced @entity957 of the XXXX .

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient', 'PATIENTS'] @entity135 :: ('MESH:D006258', 'Disease') :: ['head and neck cancer'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumor'] @entity2948 :: ('9337', 'Gene') :: ['Calif'] @entity957 :: ('MESH:D002294', 'Disease') :: ['squamous cell carcinoma'] @entity22140 :: ('MESH:D007519', 'Chemical') :: ['alloantigen'] @entity1442 :: ('MESH:D020178', 'Disease') :: ['less advanced disease'] @entity213 :: ('MESH:C535575', 'Disease') :: ['neck squamous cell carcinoma']
@entity135 :: (MESH:D006258,Disease) :: ['head and neck']
