22
Participants
Start Date
December 31, 2010
Primary Completion Date
March 31, 2013
Study Completion Date
March 31, 2013
Gene Therapy product CYL-02 = plasmid DNA pre-complexed to linear polyethylenimine encoding sst2 + dck::umk genes
Intratumoral injection of the gene therapy product CYL-02 (2,5 ml within the primary tumor under endoscopic ultrasound guidance an under propofol anaesthesia). The intratumor injection of CYL-02 is followed by three IV infusions of Gemcitabine (1000 mg/m2) at 48 hours and then every two weeks. A second Intratumoral injection of the gene therapy product CYL-02 is performed at a same dosage and volume 30 days after the first administration followed by Three infusions of gemcitabine (1000 mg/m2) according the same rhythm (48 hours and every week) and dose.
Toulouse Universitary Hospital (Rangueil), Department of Gastroenterology At Rangueil Hospital, Toulouse
Collaborators (1)
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Clinical Research Center, Toulouse
OTHER
CAYLA-INVIVOGEN
UNKNOWN
University Hospital, Toulouse
OTHER