Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00029900
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2002-01-24
Brief Title:
ADI-PEG in Patients With Metastatic Melanoma
Sponsor:
FDA Office of Orphan Products Development
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
Phase I Testing of ADI-PEG in Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2002-01
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:
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
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 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FD-R-002003-01 | None | None | None |