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Spots Global Cancer Trial Database for ADI-PEG in Patients With Metastatic Melanoma

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Trial Identification

Brief Title: ADI-PEG in Patients With Metastatic Melanoma

Official Title: Phase I Testing of ADI-PEG in Metastatic Melanoma

Study ID: NCT00029900

Interventions

ADI PEG

Study Description

Brief 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.

Detailed 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.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Northwestern University, Chicago, Illinois, United States

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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