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ADI-PEG in Patients With Metastatic Melanoma

2014-08-27 03:56:21 | BioPortfolio

Summary

This is a study to determine the safety and toxicity of increasing doses of arginine deiminase combined to polyethylene glycol (ADI-PEG) in patients with nonresectable metastatic melanoma.

Description

The use of amino acid degrading enzymes derived from microbial sources has proven to be an effective means of controlling some forms of cancer auxotrophic for nonessential amino acids. Recently it has been shown that human melanomas are auxotrophic for arginine. As arginine is a nonessential amino acid for humans, elimination of it may prove to be an effective method for controlling cancer. Laboratory studies have provided promising results with the arginine-degrading enzyme arginine deiminase (ADI) coupled to polyethylene glycol (PEG) to enhance its circulating half-life.

In this study, patients each receive 3 intramuscular treatments of ADI-SS PEG over a 4-week period. There are 4 cohorts of patients each receiving a different dose level. Pharmacokinetics, pharmacodynamics, safety and toxicity, and immunogenicity studies will be performed.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Conditions

Melanoma

Intervention

ADI PEG

Location

Northwestern University
Chicago
Illinois
United States
60611

Status

Completed

Source

FDA Office of Orphan Products Development

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:56:21-0400

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