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
18 Years
N/A
Both
Gene Therapy in Pancreatic Adenocarcinoma
Trial Information
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
This is a gene therapy open non randomized phase I trial for advanced and/or metastatic
pancreatic cancer patients. The protocol is based on the administration of increasing doses
of a plasmid DNA pre-complexed to PEI (polyethylenimine - non-viral vector) that encodes two
genes (somatostatin receptor subtype 2 named sst2 and deoxycitidine kinase ::
uridylmonophosphate kinase named dck::umk) which exhibit complementary therapeutic effects.
Both transgenes induce an antitumor bystander effect and render gemcitabine treatment more
efficient. Intratumor injections of the gene therapy product (CYL-02) will be performed by
transgastric or transduodenal route under endoscopic ultrasound guidance. Each injection
will be followed standard gemcitabine IV administration every week (1000 mg/m2). Two
intratumor injections of a same dose of CYL-02 will be administered at one month interval.
Four increasing doses (125 µg, 250 µg, 500 µg and 1 mg) will be tested by group of 6
patients. The primary objectives are: evaluation of local pancreatic and general tolerance;
the secondary objectives are: possible tumor volume regression, secondary respectability,
evaluation of transgene biodistribution.
Inclusion Criteria:
- Patient with a pancreatic adenocarcinoma histologically proven and/or a solid
pancreatic mass associated with on or multiple metastatis from pancreatic origin
(histologically proven)
- Patient with a non resectable pancreatic adenocarcinoma (on preoperative CT-scan
and/or endoscopic ultrasound evaluation)
- Pancreatic tumor that could be evaluated by endoscopic ultrasound (no digestive
stenosis, no gastrectomy)
- Patient with no contraindication to général anaesthesia.
- Karnofsky index >= 70%
- Written informed consent given
Exclusion Criteria:
- - Exclusion period for another clinical trial or research protocol.
- Patient unable to read or understand information/consent formula or unable to decide
alone for his participation to the trial
- Patient under tutelage
- Pregnant woman or able to procreate without contraception.
- Patient with pancreatic cystic tumor or pancreatic pseudocyst.
- Patient with pancreatic tumor different from adenocarcinoma (endocrine, metastasis).
- Patient contraindication to Gemzar® :
- Hypersensitivity to Gemcitabine.
- Decision of radiotherapy
- Granulocytes < 1000/mm3
- Thrombocytes < 100 000/mm3
- Patient not efficiently treated for jaundice (biliary stent or bypass) if present at
time of diagnosis
- Contraindication for fine needle aspiration biopsy under endoscopic ultrasound
(hemostasis trouble).
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Feasability and security : Number of Participants with Adverse Events
Outcome Description:
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.
Outcome Time Frame:
60 days
Safety Issue:
Yes
Principal Investigator
Louis BUSCAIL, MD,PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospital of Toulouse
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
0401401
NCT ID:
NCT01274455
Start Date:
December 2010
Completion Date:
March 2013
Related Keywords:
- Gene Therapy in Pancreatic Adenocarcinoma
- Gene therapy
- pancreatic carcinoma
- gemcitabine
- endoscopic ultrasound
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Carcinoma, Ductal, Breast
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