A phase II, multi-center, open label, randomized study to evaluate biodistribution and transmission, effectiveness and safety of two treatment regimens of Ad5CMV-p53 administered by intra-tumoral injections in 40 evaluable patients with advanced squamous

×

Foutmelding

  • Notice: Trying to access array offset on value of type null in bootstrap_pager() (regel 53 van /var/www/biosafety.be/sites/all/themes/bootstrap/templates/system/pager.func.php).
  • Notice: Trying to access array offset on value of type null in bootstrap_pager() (regel 95 van /var/www/biosafety.be/sites/all/themes/bootstrap/templates/system/pager.func.php).
Study title: 
A phase II, multi-center, open label, randomized study to evaluate biodistribution and transmission, effectiveness and safety of two treatment regimens of Ad5CMV-p53 administered by intra-tumoral injections in 40 evaluable patients with advanced squamous
Long title: 
A phase II, multi-center, open label, randomized study to evaluate biodistribution and transmission, effectiveness and safety of two treatment regimens of Ad5CMV-p53 administered by intra-tumoral injections in 40 evaluable patients with advanced squamous cell carcinoma of the head and neck (SCCHN)
Date receipt dossier: 
9 jun 1998
Pharmaceutical study code: 
Ad5CMV-p53T-207
Company / Sponsor: 
Rhone-Poulenc Rorer
Phase: 
II
Treated organism: 
Humans
Indication category: 
Cancer therapy
Disease: 
Recurrent squamous cell carcinoma of the Head and Neck
Therapeutic approach: 
Tumor suppressor gene
Genetic modification: 
Wild-type p53
Method of transfer of nucleic acid of interest: 
Human Adenovirus serotype 5
Administered biological material: 
Recombinant Adenovirus D (E3, E1A, E1B)
Route of administration: 
Intratumoral
Locations in Belgium: 
Hôpital Erasme, Bussels - Cliniques Universitaires Saint-Luc, Brussels - Universitair Ziekenhuis Antwerpen
Type of procedure: 
Contained use only
Current status: 
Authorized