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 juin 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