Artikel
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
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Autoren
Veröffentlicht: | 4. Mai 2005 |
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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.