title: Phase 2 trial of Allovectin-7 in advanced metastatic melanoma.
abstract: Treatment of metastatic melanoma with chemotherapeutic regimens has led to disappointing response rates, duration of response and no appreciable impact on survival. Intralesional injection of a low dose of an HLA-B7/beta2 microglobulin plasmid formulated with cationic lipids (Allovectin-7 is a registered trademark of Vical, Incorporated, San Diego, California, USA) has been shown previously to be safe and well tolerated. A phase 2, open-label study was performed at 16 centers in the United States. Seventy-seven patients were treated with 10 mug intralesional Allovectin-7 weekly for 6 weeks and clinical response to treatment were evaluated by World Health Organization criteria. Minimal adverse events were associated with the Allovectin-7 injections. Seven patients (9.1%) had complete or partial response with 4.8 months median duration of response. Allovectin-7 was shown to be safe and exhibit biological activity at this dose. Its safety profile may enable Allovectin-7 to be used at higher doses, which may provide greater clinical activity.
authors.affiliation: University of Colorado Cancer Center, Aurora, CO 80010-5010, USA. rene.gonzalez@uchsc.edu
authors.forename: Rene
authors.initials: R
authors.lastname: Gonzalez
authors.forename: Laura
authors.initials: L
authors.lastname: Hutchins
authors.forename: John
authors.initials: J
authors.lastname: Nemunaitis
authors.forename: Michael
authors.initials: M
authors.lastname: Atkins
authors.forename: Paul O
authors.initials: PO
authors.lastname: Schwarzenberger
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004247:DNA / Q000627:therapeutic use*; D004274:DNA, Recombinant; D018014:Gene Transfer Techniques; D015316:Genetic Therapy; D006801:Humans; D015552:Injections, Intralesional; D008055:Lipids / Q000627:therapeutic use*; D008081:Liposomes; D008297:Male; D008545:Melanoma / Q000473:pathology / Q000628:therapy*; D008875:Middle Aged; D012878:Skin Neoplasms / Q000556:secondary / Q000628:therapy*; D015996:Survival Rate; D016896:Treatment Outcome; D014481:United States
chemical_list: C096492:Allovectin-7; D004274:DNA, Recombinant; D008055:Lipids; D008081:Liposomes; D004247:DNA