ClinicalTrials.Veeva

Menu

Gene Therapy of Pancreatic Ductal Adenocarcinoma (TherGAP)

T

Toulouse University Hospital

Status and phase

Completed
Phase 1

Conditions

Pancreatic Adenocarcinoma

Treatments

Genetic: Gene Therapy product CYL-02 = plasmid DNA pre-complexed to linear polyethylenimine encoding sst2 + dck::umk genes

Study type

Interventional

Funder types

Other

Identifiers

NCT01274455
0401401

Details and patient eligibility

About

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

22 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

22 participants in 1 patient group

Therapy
Experimental group
Treatment:
Genetic: Gene Therapy product CYL-02 = plasmid DNA pre-complexed to linear polyethylenimine encoding sst2 + dck::umk genes

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems