Long title
A phase III, multi-center, open-label, randomized study to compare the overall survival and safety of bi-weekly intratumoral administration of INGN 201 versus weekly methotrewate in 240 patients with refractory 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
Refractory 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
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) - T301