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

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Study 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
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: 
9 nov 2001
Pharmaceutical study code: 
INGN 201 (Ad5CMV-p53) - T302
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