Carboxypeptidase-G2 in Treating Nervous System Toxic Effects in Patients Given an Overdose of Intrathecal Methotrexate
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.
|Neurotoxicity Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific||Drug: glucarpidase|
|Study Design:||Masking: None (Open Label)
Primary Purpose: Supportive Care
|Official Title:||A Trial of Carboxypeptidase-G2 (CPDG2) For The Management of Patients With Intrathecal Methotrexate Overdose|
|Study Start Date:||November 1993|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00018967
Show 103 Study Locations
|Study Chair:||Brigitte C. Widemann, MD||National Cancer Institute (NCI)|