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

2014-08-27 03:16:47 | BioPortfolio

Summary

The objective of the present trial is to evaluate the tolerability and the 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 in man.

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.

Study Design

Control: Dose Comparison, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Melanoma

Intervention

naked DNA coding for protein AMEP

Location

Copenhagen University Hospital Herlev
Herlev
Denmark
2730

Status

Recruiting

Source

BioAlliance Pharma SA

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:47-0400

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A melanosome-specific protein that plays a role in the expression, stability, trafficking, and processing of GP100 MELANOMA ANTIGEN, which is critical to the formation of Stage II MELANOSOMES. The protein is used as an antigen marker for MELANOMA cells.

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Experimentally induced tumor that produces MELANIN in animals to provide a model for studying human MELANOMA.

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The infective system of a virus, composed of the viral genome, a protein core, and a protein coat called a capsid, which may be naked or enclosed in a lipoprotein envelope called the peplos.

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