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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00018967

Enrollment

Registered

2003-01-27

Start date

1993-11-30

Completion date

Unknown

Last updated

2015-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurotoxicity, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific

Keywords

unspecified childhood solid tumor, protocol specific, unspecified adult solid tumor, protocol specific, neurotoxicity

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.

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.

Interventions

DRUGglucarpidase

Study design

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * Patients who received an intrathecal overdose of methotrexate of 100 mg or more PATIENT CHARACTERISTICS: Age: * Any age Performance status: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No prior anaphylactic reaction to carboxypeptidase-G2 administration PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * Concurrent therapy allowed

Countries

Australia, Canada, Switzerland, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026