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
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
Pharmaceutical study code
Ad5CMV-p53T-207