Long title
Prospective, open-label, parallel-group, randomized, multicenter trial comparing the efficacy of surgery, radiation, and injection of murine cells producing herpes simplex thymidine kinase vector followed by intravenous ganciclovir against the efficacy of surgery and radiation in the treatment of newly diagnosed, previously untreated gliogblastoma
Date receipt dossier
Company / Sponsor
Genetic therapy, Inc., Sandoz Pharma, Ltd
Phase
III
Treated organism
Humans
Indication category
Cancer therapy
Disease
Newly diagnosed previously untreated Glioblastoma
Therapeutic approach
Suicide gene/ pro drug
Genetic modification
Thymidine Kinase (HSV-TK1), neomycin resistance (NeoR)
Method of transfer of nucleic acid of interest
Amphotropic Murine Leukemia Virus
Administered biological material
Retroviral vector producing cells (PA 317)
Route of administration
Intratumoral
Locations in Belgium
Hôpital Erasme, Brussels - Universitair Ziekenhuis Antwerpen
Type of procedure
Contained use only
Current status
Authorized
Pharmaceutical study code
GTI-0115