Phase I Testing of ADI-PEG in Metastatic Melanoma
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
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment
United States: Food and Drug Administration
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