Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001298
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
A Trial of Carboxypeptidase-G2 CPDG2 and Thymidine for the Management of Patients With Methotrexate Toxicity and Renal Dysfunction
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Trial of Carboxypeptidase-G2 CPDG2 and Thymidine for the Management of Patients With Methotrexate Toxicity and Renal Dysfunction
Status:
COMPLETED
Status Verified Date:
2000-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
High dose methotrexate with leucovorin rescue has demonstrated activity in numerous malignancies Although high dose methotrexate is generally well tolerated unpredictable life-threatening toxicity can occur For patients who have markedly delayed clearance of methotrexate secondary to renal dysfunction therapeutic options are few and are of limited efficacy Carboxypeptidase-G2 inactivates methotrexate by hydrolyzing its C-terminal glutamate residue Carboxypeptidase-G2 could be used to rescue patients with renal dysfunction and delayed methotrexate excretion as it provides an alternative to renal clearance as a route of elimination
Detailed Description:
High dose methotrexate with leucovorin rescue has demonstrated activity in numerous malignancies Although high dose methotrexate is generally well tolerated unpredictable life-threatening toxicity can occur For patients who have markedly delayed clearance of methotrexate secondary to renal dysfunction therapeutic options are few and are of limited efficacy Carboxypeptidase-G2 inactivates methotrexate by hydrolyzing its C-terminal glutamate residue Carboxypeptidase-G2 could be used to rescue patients with renal dysfunction and delayed methotrexate excretion as it provides an alternative to renal clearance as a route of elimination
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 |
|---|---|---|---|
| 92-C-0134 | None | None | None |