ADI-PEG in Patients With Metastatic Melanoma

Phase 1

Completed

• Conditions: Melanoma; Neoplasm Metastasis

• Registration Number: NCT00029900
• Lead Sponsor: FDA Office of Orphan Products Development

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.

Study Timeline

• Study Start: 2001-09
• Status Verified: 2002-01
• Study First Submitted: 2002-01-24
• Study First Submitted QC: 2002-01-24
• Study First Posted: 2002-01-25
• Study Completion: 2003-08
• Last Update Submitted: 2015-03-24
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States