Spots Global Cancer Trial Database for Safety and Efficacy Study of Electrotransfer of Plasmid AMEP to Treat Advanced or Metastatic Melanoma
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Trial Identification
Brief Title: Safety and Efficacy Study of Electrotransfer of Plasmid AMEP to Treat Advanced or Metastatic Melanoma
Official Title: Safety and Efficacy of Intratumoural Electrotransfer of Plasmid AMEP in Patients Suffering From Advanced or Metastatic Melanoma: an Open Phase 1 Trial
Study ID: NCT01045915
Conditions
Interventions
Study Description
Brief Summary: The objective of the present trial is to evaluate the local and general safety of the intratumoural electrotransfer of increasing doses of Plasmid AMEP in patients suffering from advanced or metastatic melanoma and to identify doses that could be effective on cutaneous lesions in man.
Detailed Description: In this open, multicentre, dose escalation study, successive cohorts of 3 patients suffering from advanced or metastatic melanoma will be electrotransferred increasing doses of Plasmid AMEP into cutaneous melanoma lesions in 2 divided doses at one week interval.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Copenhagen University Hospital Herlev, Herlev, , Denmark
Gustave Roussy Institute, Kremlin Bicetre, , France
Institute of Oncology Ljubljana, Ljubljana, , Slovenia
Contact Details
Name: ATTALI Pierre, MD
Affiliation: BioAlliance Pharma
Role: STUDY_DIRECTOR
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