Clinical research program : Gene-therapy by the Use of a Recombinant Adenovirus in the Treatment of p53 Deficient Cancers

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Study title: 
Clinical research program : Gene-therapy by the Use of a Recombinant Adenovirus in the Treatment of p53 Deficient Cancers
EU record number: 
B/BE/98/B6
Pharmaceutical study code: 
I98-102
Company / Sponsor: 
Schering Plough NV/SA
Treated organism: 
Humans
Indication category: 
Cancer therapy
Disease: 
Ovarian and primary peritoneal cancer
Therapeutic approach: 
Tumor suppressor gene
Genetic modification: 
wild-type p53 tumor suppressor gene
Method of transfer of nucleic acid of interest: 
Human Adenovirus serotype 5
Administered biological material: 
Recombinant Adenovirus D (E3, E1A, E1B, pIX)
Route of administration: 
Intraperitoneal
Locations in Belgium: 
Cliniques Universitaires Saint-Luc, Brussels - Akademisch Ziekenhuis, Vrije Universiteit Brussel - Hôpital Erasme, Brussels - Akademisch Ziekenhuis St Augustinus, Wilrijk
Nr of subjects: 
not specified (up to 360 worldwide)
Type of procedure: 
Contained use and Deliberate release
Current status: 
Authorized

Information related to the decision procedure