Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00056992
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2003-03-26
Brief Title:
Testing of ADI-PEG in Hepatocellular Carcinoma
Sponsor:
FDA Office of Orphan Products Development
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
Phase II Testing of ADI-PEG in Hepatocellular Carcinoma
Status:
COMPLETED
Status Verified Date:
2002-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 IUm2 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
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 IUm2 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None