gms | German Medical Science

56. Jahrestagung der Deutschen Gesellschaft für Neurochirurgie e. V. (DGNC)
3èmes journées françaises de Neurochirurgie (SFNC)

Deutsche Gesellschaft für Neurochirurgie e. V.
Société Française de Neurochirurgie

07. bis 11.05.2005, Strasbourg

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Gene therapy for high-grade glioma with an adenoviral vector containing the Herpes Simplex virus thymidine kinase gene (Cerepro™): From pre clinical studies to a randomised phase II survival study

Meeting Abstract

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  • corresponding author A.-M. Sandmair - Department of Neurosurgery, University of Kuopio, Kuopio, Finnland
  • M. Vapalahti - Department of Neurosurgery, University of Kuopio, Kuopio, Finnland
  • A. Immonen - Department of Neurosurgery, Kuopio University Hospital, Kuopio Finland
  • K. Tynnela - Department of Oncology, Kuopio University Hospital, Kuopio Finland
  • H. Hurskainen - Department of Neurosurgery, Kuopio University Hospital, Kuopio Finland
  • R. Vanninen - Department of Radiology, Kuopio University Hospital, Kuopio Finland
  • G. Langford - Ark Therapeutics Ltd., London, UK
  • N. Murray - Ark Therapeutics Ltd., London, UK
  • S. Ylä-Herttuala - Department of Molecular Medicine, A.J Virtanen Institute

Deutsche Gesellschaft für Neurochirurgie. Société Française de Neurochirurgie. 56. Jahrestagung der Deutschen Gesellschaft für Neurochirurgie e.V. (DGNC), 3èmes journées françaises de Neurochirurgie (SFNC). Strasbourg, 07.-11.05.2005. Düsseldorf, Köln: German Medical Science; 2005. Doc10.05.-09.06

Die elektronische Version dieses Artikels ist vollständig und ist verfügbar unter: http://www.egms.de/de/meetings/dgnc2005/05dgnc0131.shtml

Veröffentlicht: 4. Mai 2005

© 2005 Sandmair et al.
Dieser Artikel ist ein Open Access-Artikel und steht unter den Creative Commons Lizenzbedingungen (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.de). Er darf vervielfältigt, verbreitet und öffentlich zugänglich gemacht werden, vorausgesetzt dass Autor und Quelle genannt werden.

Gliederung

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Objective

The aim of these studies was to evaluate the efficacy and safety of CereproTM (Herpes Simplex virus thymidine kinase in an adenoviral vector AdvHSV-tk) with intravenous Ganciclovir in pre clinical animal model as in patients with operable high grade glioma. Our randomised, controlled, phase II study involved 36 patients with operable primary or recurrent high-grade glioma.

Methods

Patients were randomised in phase II study either to receive CereproTM (3x1010 pfu) by local injection into the walls of the tumor cavity at the time of tumour resection, followed by intravenous ganciclovir, 5mg/kg twice daily for 14 days (n=17) or standard care consisting of radical excision (n=19). Patients in both groups with primary tumours received postoperative radiotherapy.

Results

In the phase II study, there was an increased mean survival from 39.0±19.7 (SD) in control group to 70.652.9 weeks in the treatment group (p=0.0095) following CereproTM therapy. Median survival increased from 37.7 to 62.4 weeks. The percentage increase in mean survival was 81% and median survival was 65%. This therapy was well tolerated according to adverse events, clinical chemistry, haematology and immunology. There was no evidence of any deterioration in quality of life or increased use of concomitant medications.

Conclusions

CereproTM (Herpes Simplex virus thymidine kinase in an adenoviral vector AdvHSV-tk) with ganciclovir is a novel, safe, promising therapy for operable malignant glioma.