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Near 85% of patients with pancreatic adenocarcinoma are diagnosed with a locally advanced and/or metastatic unresectable tumor. In these patients chemotherapy (such as gemcitabine) is given as a palliative therapy. Aim of the present study is to evaluate the feasibility, tolerance and antitumor effect of repeated intratumoral injection of a gene therapy product (with antitumor and chemo sensitizing effects) combined with gemcitabine in patients with unresectable pancreatic carcinoma.
Full description
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.
Enrollment
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Inclusion criteria
Exclusion criteria
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® :
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).
Primary purpose
Allocation
Interventional model
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22 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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