A Controlled, Randomised, Parallel Group, Multicentre Study of the Efficacy and Safety of Herpes Simplex Virus-Thymidine Kinase Gene Therapy (CereproTM), with Subsequent Ganciclovir, for the Treatment of Patients with Operable High-Grade Glioma

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Study title: 
A Controlled, Randomised, Parallel Group, Multicentre Study of the Efficacy and Safety of Herpes Simplex Virus-Thymidine Kinase Gene Therapy (CereproTM), with Subsequent Ganciclovir, for the Treatment of Patients with Operable High-Grade Glioma
Date receipt dossier: 
1 Feb 2005
EudraCT number: 
2004-000464-28
Pharmaceutical study code: 
Protocol 904
Company / Sponsor: 
Ark Therapeutics Ltd
Phase: 
III
Treated organism: 
Humans
Indication category: 
Cancer therapy
Disease: 
Operable high-grade glioma
Therapeutic approach: 
Suicide gene/ pro drug
Genetic modification: 
Thymidine Kinase (HSV-TK1)
Method of transfer of nucleic acid of interest: 
Human Adenovirus serotype 5
Administered biological material: 
Recombinant Adenovirus D (E1, E3)
Route of administration: 
Intratumoral
Locations in Belgium: 
Academisch Ziekenhuis - Vrije Universiteit Brussel; Cliniques Universitaires de Bruxelles - Hôpital Erasme; Centre Hospitalier Universitaire de Liège.
Type of procedure: 
Contained use only
Current status: 
Authorized