Study 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
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:
9 Nov 2001
Pharmaceutical study code:
INGN 201 (Ad5CMV-p53) - T301
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