Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00018967
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2001-07-11
Brief Title:
Carboxypeptidase-G2 in Treating Nervous System Toxic Effects in Patients Given an Overdose of Intrathecal Methotrexate
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Trial of Carboxypeptidase-G2 CPDG2 For The Management of Patients With Intrathecal Methotrexate Overdose
Status:
COMPLETED
Status Verified Date:
2007-04
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:
RATIONALE Chemoprotective drugs such as carboxypeptidase-G2 may protect normal cells from the toxic effects of chemotherapy
PURPOSE Clinical trial to study the effectiveness of carboxypeptidase-G2 in treating nervous system toxic effects in patients given an accidental overdose of intrathecal methotrexate
PURPOSE Clinical trial to study the effectiveness of carboxypeptidase-G2 in treating nervous system toxic effects in patients given an accidental overdose of intrathecal methotrexate
Detailed Description:
OBJECTIVES
Determine the effectiveness of carboxypeptidase-G2 rescue in patients who develop life threatening methotrexate MTX neurotoxicity following accidental intrathecal MTX overdose
Study the CSF pharmacokinetics of MTX following rescue
OUTLINE Patients undergo a lumbar puncture as soon as possible after methotrexate overdose to remove methotrexate and receive a single dose of carboxypeptidase-G2 intrathecally over 5 minutes
Patients are followed for at least 1 month
PROJECTED ACCRUAL A maximum of 10 patients will be accrued for this study
Determine the effectiveness of carboxypeptidase-G2 rescue in patients who develop life threatening methotrexate MTX neurotoxicity following accidental intrathecal MTX overdose
Study the CSF pharmacokinetics of MTX following rescue
OUTLINE Patients undergo a lumbar puncture as soon as possible after methotrexate overdose to remove methotrexate and receive a single dose of carboxypeptidase-G2 intrathecally over 5 minutes
Patients are followed for at least 1 month
PROJECTED ACCRUAL A maximum of 10 patients will be accrued for this study
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 |
|---|---|---|---|
| COG-P9688 | None | None | None |
| NCI-92-C-0137N | None | None | None |
| CCG-0923 | None | None | None |
| POG-9688 | None | None | None |
| NCI-T92-0021N | None | None | None |
| COG-0923 | None | None | None |