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

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

Pharmaceutical study code

I95-177-03

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