NCT00029900

ADI-PEG in Patients With Metastatic Melanoma

Phase I Testing of ADI-PEG in Metastatic Melanoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (planned)
• Sponsor: FDA Office of Orphan Products Development · Federal
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma
• Neoplasm Metastasis

Interventions

Type	Name	Description
DRUG	ADI PEG

Timeline

• Start date: 2001-09-01
• Completion: 2003-08-01
• First posted: 2002-01-25
• Last updated: 2015-03-25

Locations

1 site across 1 country: United States