B/BE/98/B6
| Company/Institution | Schering Plough NV/SA |
| Parental organism | Human Adenovirus serotype 5 |
| Transgene(s) | wild-type p53 tumor suppressor gene |
| Treated organism | Humans |
| Title of the project | Clinical research program : Gene-therapy by the Use of a Recombinant Adenovirus in the Treatment of p53 Deficient Cancers |
| Treatment indication | newly diagnosed stage III ovarian and primary peritoneal cancer |
| Administration route(s) | Intraperitoneal |
| Total number of subjects foreseen | not specified (up to 360 worldwide) |
| Foreseen duration of release | |
| Effective year(s) of release | 2 years |
| Current status | Authorization procedure completed. The notifier was granted authorization from the Federal Minister to perform the trial. Trial completed (study terminated after 132 patients were enrolled). |
| Locations | Cliniques Universitaires Saint-Luc, Brussels - Akademisch Ziekenhuis, Vrije Universiteit Brussel - Hôpital Erasme, Brussels - Akademisch Ziekenhuis St Augustinus, Wilrijk |
| Number of sites | 4 |
| Monitoring | |
| Type of procedure | Classical procedure - Art. 9§1 of Royal Decree of 18 December 1998 |
| Notes | |
| Other |
Information for the public
Information related to the decision procedure
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B/BE/98/B6 - Advice of the Division of Biosafety and Biotechnology (SBB)
2 June 1999 - The SBB issues a positive advice (with conditions) for this trial.
