Neurological Surgery No Shinkei Geka Volume 28, Issue 11 (November 2000)

The Biosafety of the HSV-TK/GCV Gene Therapy in Five Cases of Recurrent Glioblastoma Multiforme Naoto ADACHI 1,2,3 , Karl Frei 2,3 , Yasuhiro YONEKAWA 2,3 1Department of Neurosurgery, Clinical Neuroscience, Yamaguchi University School of Medicine 2Department of Neurosurgery, University Hospital Zürich Keyword: biosafety , ganciclovir , gene therapy , glioblastoma multiforme , herpes simplex virus-thymidine kinase pp.965-974
Published Date 2000/11/10
  • Abstract
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 Herpes simplex virus-thymidine kinase/ganciclovir (HSV-TK/GCV) therapy was performed in five cases of recurrent glioblastoma multiforme. In the last study, the authors demonstrated response of the HSV-TK/GCV therapy against tumor progression (Adachi N, et al.: No Shinkei Geka). The aim of this study is to estimate the biosafty of in vivo HSV-TK gene transfer and GCV administration in five cases.Six parameters were analyzed sequentially up to the 6th month after the vector producer cells (VPCs) inoculation as follows; ⅰ) clinical symptom, ⅱ) vital sign, ⅲ) peripheral blood cell count, ⅳ) blood biochemical analysis, ⅴ) serological test, ⅵ) molecular biological test in peripheral leukocytes. In addition, ten systemic organs extracted from the two subjects in whom death occured were also analyzed biologically. One case suffered from transient deterioration of left hemiparesis on the 34th day, which could be considered a probably-related but not adverse event. Serological tests detected anti-VPC antibody at the 1st month in one case and anti-vector antibody at the 1st and 4th month in another. The other examinations revealed no abnormal findings at all. These data indicate that the HSV-TK/GCV therapy might be a satisfactorily safe approach against glioblastoma multiforme.

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Neurological Surgery 脳神経外科
28巻11号 (2000年11月)
電子版ISSN 1882-1251 印刷版ISSN 0301-2603 医学書院