Trials / Completed
CompletedNCT00018967
Carboxypeptidase-G2 in Treating Nervous System Toxic Effects in Patients Given an Overdose of Intrathecal Methotrexate
A Trial of Carboxypeptidase-G2 (CPDG2) For The Management of Patients With Intrathecal Methotrexate Overdose
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
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.
Conditions
- Neurotoxicity
- Unspecified Adult Solid Tumor, Protocol Specific
- Unspecified Childhood Solid Tumor, Protocol Specific
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | glucarpidase |
Timeline
- Start date
- 1993-11-01
- Primary completion
- 2007-04-01
- First posted
- 2003-01-27
- Last updated
- 2015-04-30
Locations
103 sites across 4 countries: United States, Australia, Canada, Switzerland
Source: ClinicalTrials.gov record NCT00018967. Inclusion in this directory is not an endorsement.