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

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

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