Study title:
A phase I study in patients with recurrent or metastatic squamous cell carcinoma of the head and neck using SCH 58500 (rAd/p53) administered by single intratumoral injection
Date receipt dossier:
21 oct 1996
Pharmaceutical study code:
I95-177-03
Company / Sponsor:
Schering Plough NV/SA
Phase:
I
Treated organism:
Humans
Indication category:
Cancer therapy
Disease:
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, pIX)
Route of administration:
Intratumoral
Locations in Belgium:
Universitair Ziekenhuis Gasthuisberg, Leuven
Type of procedure:
Contained use only
Current status:
Authorized