Long title
A phase III, multi-center, open-label, randomized study to compare the effectiveness and safety of intratumoral administration of INGN 201 in combination with chemotherapy versus chemotherapy alone in 288 patients with recurrent squamous cell carcinoma of the head and neck (SCCHN)
Date receipt dossier
Company / Sponsor
Introgen Therapeutics, Inc.
Phase
III
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
Cliniques Universitaires Saint-Luc, Brussels - Akademisch Ziekenhuis, Vrije Universiteit Brussel
Nr of subjects
240
Type of procedure
Contained use only
Current status
Authorized
Notes
sponsor decided to cancel the trial in Belgium
Pharmaceutical study code
INGN 201 (Ad5CMV-p53) - T302