Gene Therapy of Pancreatic Ductal Adenocarcinoma (TherGAP)
|ClinicalTrials.gov Identifier: NCT01274455|
Recruitment Status : Completed
First Posted : January 11, 2011
Last Update Posted : March 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Adenocarcinoma||Genetic: Gene Therapy product CYL-02 = plasmid DNA pre-complexed to linear polyethylenimine encoding sst2 + dck::umk genes||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PILOT STUDY OF GENE THERAPY FOR LOCALLY ADVANCED PANCREATIC ADENOCARCINOMA WITH INTRATUMOURAL INJECTION OF JetPEI/DNA COMPLEXES WITH ANTITUMOURAL EFFECT AND CHEMOSENSITIZING ACTIVITY FOR GEMCITABINE|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
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.
- Feasability and security : Number of Participants with Adverse Events [ Time Frame: 60 days ]Feasibility, security (pancreas and general) of intratumor injections of the gene therapy product (CYL-02 plasmid DNA pre-complexed to PEI encoding sst2 dck::umk) administered under endoscopic ultrasound guidance and followed by gemcitabine treatment at standard doses.
- Antitumoral effect: secondary resecability, transgenes diffusion [ Time Frame: 60 days ]antitumoral effect, secondary resecability, transgenes diffusion (urine and blood) and expression (tumor).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01274455
|Toulouse Universitary Hospital (Rangueil), Department of Gastroenterology At Rangueil Hospital|
|Toulouse, France, 31059|
|Principal Investigator:||Louis BUSCAIL, MD,PhD||University Hospital of Toulouse|