ADI-PEG in Patients With Metastatic Melanoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00029900|
Recruitment Status : Completed
First Posted : January 25, 2002
Last Update Posted : March 25, 2015
|Condition or disease||Intervention/treatment||Phase|
|Melanoma Neoplasm Metastasis||Drug: ADI PEG||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Enrollment :||15 participants|
|Masking:||None (Open Label)|
|Official Title:||Phase I Testing of ADI-PEG in Metastatic Melanoma|
|Study Start Date :||September 2001|
|Study Completion Date :||August 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00029900
|United States, Illinois|
|Chicago, Illinois, United States, 60611|