Testing of ADI-PEG in Hepatocellular Carcinoma
|ClinicalTrials.gov Identifier: NCT00056992|
Recruitment Status : Completed
First Posted : March 27, 2003
Last Update Posted : March 25, 2015
Amino acid deprivation therapy is an effective means for the treatment of some forms of cancer. Recently it has been found that human hepatocellular carcinomas (HCC) cell lines appear to require arginine for growth. Arginine is not an essential amino acid for human adults or infants as it can be synthesized from citrulline (for review see Rogers 1994). Therefore, selective elimination of arginine from the circulation may be a means of treating patients with metastatic melanoma or non resectable HCC.
The enzyme arginine deiminase (ADI) metabolizes arginine into citrulline (Cunin 1986). However, ADI is only found in microbes and not in humans. ADI is therefore, highly immunogenic and has a short serum half-life following injection. These potential drawbacks (microbial source and thus viewed as foreign by the human immune system, and a short serum half-life) can be overcome by covalent attachment of polyethylene glycol (PEG) to argininedeiminase and termed this drug ADI-PEG 20.
ADI-PEG 20 appears to be an effective anti-cancer treatment for human HCC. Pharmacokinetic and pharmacodynamic data indicates a once a week injection of 160 IU/m2 of ADI-PEG 20 eliminates all detectable arginine from the circulation for at least 7 days. This treatment appears to be well tolerated. The purpose of this study is to determine the efficacy of this treatment in patients with HCC. Efficacy is a primary end point of this study. No patients will recieve placebo.
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Hepatocellular||Drug: ADI-PEG 20||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Testing of ADI-PEG in Hepatocellular Carcinoma|
|Study Start Date :||September 2002|
|Estimated Study Completion Date :||October 2003|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00056992
|United States, Texas|
|MD Anderson Cancer center|
|Houston, Texas, United States|