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

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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