Gene Therapy of Pancreatic Ductal Adenocarcinoma

PHASE1CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

December 31, 2010

Primary Completion Date

March 31, 2013

Study Completion Date

March 31, 2013

Conditions
Pancreatic Adenocarcinoma
Interventions
GENETIC

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.

Trial Locations (1)

31059

Toulouse Universitary Hospital (Rangueil), Department of Gastroenterology At Rangueil Hospital, Toulouse

Sponsors
All Listed Sponsors
collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

collaborator

Clinical Research Center, Toulouse

OTHER

collaborator

CAYLA-INVIVOGEN

UNKNOWN

lead

University Hospital, Toulouse

OTHER