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

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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