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Completed

NCT Number: NCT00018967

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.

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Key information

Conditions

Neurotoxicity Chemically-Induced Disorders Nervous System Diseases Neurotoxicity Syndromes Poisoning Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Westmead Institute for Cancer Research at Westmead Hospital, Westmead, New South Wales, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

glucarpidase

Drug

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Collaborators

  • Children's Oncology Group

Registry information

Official study title

A Trial of Carboxypeptidase-G2 (CPDG2) For The Management of Patients With Intrathecal Methotrexate Overdose

Important dates

Study start
1993
Primary completion
2007
First posted
Jan 27, 2003
Registry last updated
Apr 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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