NCT01045915

Safety and Efficacy Study of Electrotransfer of Plasmid AMEP to Treat Advanced or Metastatic Melanoma

Safety and Efficacy of Intratumoural Electrotransfer of Plasmid AMEP in Patients Suffering From Advanced or Metastatic Melanoma: an Open Phase 1 Trial

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Valerio Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	naked DNA coding for protein AMEP	2 injections 1 week interval of 4 increasing doses of plasmid with electrotransfer

Timeline

• Start date: 2010-07-01
• Primary completion: 2012-06-01
• Completion: 2013-01-01
• First posted: 2010-01-11
• Last updated: 2015-09-11

Locations

3 sites across 3 countries: Denmark, France, Slovenia