Study 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
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:
24 oct 1996
Pharmaceutical study code:
GTI-0115
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