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Volume 2
     

European standard operating procedures for electrochemotherapy and electrogenetherapy (ESOPE)

   
Project

QLK3-2002-02003

Cell factory area

3.1.3

EU Contribution

892,994 Euro

Duration

36 months

Type

DM

Starting date

Foreseen 01 January 2003 (contract not yet signed at date of printing)

Keywords
antitumour therapy
Electroporation
ethical autorisation
tolerance scales
ABSTRACT

The objective of ESOPE is to validate the clinical applications of electroporation of cells in tissues and to establish standard operating procedures (SOP) for their standardised use and rapid dissemination in Europe. These applications are antitumour electrochemotherapy and electrogenetherapy (i.e. DNA electrotransfer in vivo for a new non-viral gene therapy). The project benefits from new European equipment developed within the 5th PCRD, equipment designed to deliver only the electrical energy necessary to achieve in vivo electroporation, ensuring patient safety as well as the reliability and efficacy of in vivo drug and gene delivery.

OBJECTIVES

The objective of ESOPE is to validate the clinical applications of electroporation of cells in tissues, the antitumour electrochemotherapy and electrogenetherapy (i.e. DNA electrotransfer in vivo for a new non-viral gene therapy) and to establish standard operating procedures (SOP) for their standardised use and rapid dissemination in Europe.

The objectives of the ESOPE project will be achieved by:

  1. controlled application of the treatments according to predefined guidelines.
  2. evaluation of the procedures and of the results.
  3. definition of SOP.
  4. dissemination of these therapies by the preparation of educational and training material, the certification of teams, the organisation of a large meeting for users' information, and the establishment of appropriate contacts with the national and EU regulatory agencies and health organisations.
DESCRIPTION OF THE WORK

In an initial meeting, the ESOPE consortium will establish definite guidelines for antitumour electrochemotherapy (ECT) and will define data to be collected for clinical results analysis as well as for quality of life and health economics evaluation. These data will be stored in a database that the consortium will develop.

The consortium will also create a website for internal as well as for external communication. The project foresees the treatment of 120 patients in four cancer centres in a first phase (10 months), to verify the feasibility of the guidelines and the efficacy of the ECT using the new equipment that has being developed within the 5th PCRD. During this phase, partners will also obtain authorisations for electrogenetherapy (EGT) from ethics committees, and if necessary from other national agencies. Then the consortium will gather to evaluate ECT procedures and to establish ECT SOP (SOP for the patient's eligibility, the anaesthesia, the choice of agents, route and dose, the treatment and the follow-up), as well as the guidelines for EGT. In a second phase (10 months), 20 patients per centre will be treated to validate ECT SOP, and five patients per centre will be treated by EGT to assess tolerance, procedure and efficacy of the DNA transfer, using a non-immunogenic reporter gene. In a third consortium meeting, EGT SOP will be established, and all material for rapid dissemination of ECT and EGT will be prepared. Using the database, quality of life and health economics will be evaluated, as well as the overall results of the treatments. The results of quality control during the project will also be reported.

Last phase (four months) will be devoted to dissemination through the organisation of a large users' meeting, the training of future users (five patients treated per centre) and the certification of teams, the establishment of appropriate contacts with the national and EU regulatory agencies and health organisations, the preparation and diffusion of educational and training material (phantoms, videos, booklets, etc.).

DELIVERABLES

Deliverables and expected results are:

  1. establishment of tolerance scales for electrochemotherapy (ECT) and assessment.
  2. preparation of SOP for ECT and validation.
  3. clearance of authorisations from ethical committees for electrogenetherapy (EGT) trials in humans.
  4. tolerance scales and SOP for EGT.
  5. constitution of ECT and EGT databases and analysis in terms of treatments efficacy, quality of life and health economics.
  6. dissemination through a users' meeting, diffusion of educational and training materials, certification of teams and contacts with national and EU regulatory bodies.
CONSORTIUM
COORDINATOR
 
Lluis M. Mir
FRE 2530 CNRS
Institut Gustave-Roussy
94805 Villejuif Cedex, France
Tel: +33-1-42 11 47 92
Fax: +33-1-42 11 52 45
luismir@igr.fr
 
PARTNERS
 
Ruggero Cadossi
IGEA S.r.l.
41012 Carpi, Italy
Tel: +39-059-699 600
Fax: +39-059-695 778
cadossi@igea.it

Julie Gehl
Dept. of Oncology
Herlev Hospital
2730 Herlev, Denmark
Tel: +45-44 88 4488, ext 3044/3058
Fax: +45-44 53 3077
julie@herlevhosp.kbhamt.dk

Gregor Sersa
Lab. of Radiation Biology
Inst. of Oncology
1000 Ljubljana, Slovenia
Tel: +386-1-433 74 10
Fax: +386-1-433 74 10
gsersa@onko-i.si

Gerald O'Sullivan
Cork Cancer Research Centre
Mercy Hospital
Cork, Ireland
Tel: +353-21-427 19 71
Fax: +353-21-427 98 96
geraldc@iol.ie
c.dunne@ucc.ie