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59. Jahrestagung der Deutschen Gesellschaft für Neurochirurgie (DGNC)
3. Joint Meeting mit der Italienischen Gesellschaft für Neurochirurgie (SINch)

Deutsche Gesellschaft für Neurochirurgie (DGNC) e. V.

01. - 04.06.2008, Würzburg

An international multicenter, randomized phase III trial for suicide gene therapy with the HSV TK gene using direct application of adenoviral gene transfer

Eine internationale Phase III Studie zur Sicherheit und Wirksamkeit eines adenoviralen Gentransfers der Herpes simplex Virus Thymidin Kinase nach Resektion neu diagnostizierter Glioblastome

Meeting Abstract

  • corresponding author M. Westphal - University Hospital Hamburg-Eppendorf, Hamburg
  • Z. Ram - University Hospital Hamburg-Eppendorf, Hamburg
  • D. Eckland - University Hospital Hamburg-Eppendorf, Hamburg
  • P. Menei - University Hospital Hamburg-Eppendorf, Hamburg
  • S. Yla-Herrtualy - University Hospital Hamburg-Eppendorf, Hamburg

Deutsche Gesellschaft für Neurochirurgie. Società Italiana di Neurochirurgia. 59. Jahrestagung der Deutschen Gesellschaft für Neurochirurgie e.V. (DGNC), 3. Joint Meeting mit der Italienischen Gesellschaft für Neurochirurgie (SINch). Würzburg, 01.-04.06.2008. Düsseldorf: German Medical Science GMS Publishing House; 2008. DocMO.13.08

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Veröffentlicht: 30. Mai 2008

© 2008 Westphal et al.
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For the Cerepro Study Group

Objective: To assess the safety and efficacy of adenoviral gene transfer of a suicide gene (herpes simplex virus thymidine kinase, HSV-TK, Cerepro® (sitimagene ceradenovec) after resection of newly diagnosed glioblastoma.

Methods: 250 patients were recruited for a randomized trial in which immediately after resection, 10 ml equivalent to 1012 viral particles a HSV-TK transducing adenovirus were injected into multiple sites (up to 80) of the resection cavity wall into a depth of about 10 mm. After an incubation time of 5 days Ganciclovir was given intravenously for 14 days. The randomization was against standard care only which was postoperative radiation with or without concomitant Temozolamide, depending on general practice in the participating countries. Primary endpoint is time to death or reintervention, the primary secondary endpoint is overall survival.

Results: 250 patients were recruited in 38 European centers between November 2005 and April 2007. The first post accrual meeting of the data safety monitoring board identified no safety issues and recommended to continue the study with data collection until the next interim analysis in January of 2008. 152 serious adverse events were reported, 92 in the Cerepro group and 60in the control arm. The neurological SAEs were associated with preexisting deficits and are considered to be related to the tumor location and not the reagent. The SAE profile was not different between the two groups. 90 blood samples from 28 patients were tested for presence of vector and only in two, vector was found transiently just above the level of detection.

Conclusions: An international phase III trial for a gene therapy approach to glioblastoma was completed in the first quarter of 2007. This is only the second phase III for gene directed enzyme prodrug therapy for glioblastoma ever. Given the form of application via up to 70 single intraparenchymal injections, the safety profile has proven to be benign. The evaluation of the study is ongoing and no issues have been identified to prematurely conclude the trial futile. The final result is expected for the first quarter of 2008.