Gene Therapy of Pancreatic Ductal Adenocarcinoma (TherGAP)
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|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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|