Carboxypeptidase-G2 in Treating Nervous System Toxic Effects in Patients Given an Overdose of Intrathecal Methotrexate

This study has been completed.

First Received: July 11, 2001 Last Updated: May 9, 2009 History of Changes

Sponsor:	National Cancer Institute (NCI)
Collaborator:	Children's Oncology Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00018967

Purpose

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.

Condition	Intervention
Neurotoxicity Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific	Drug: glucarpidase

Study Type:	Interventional
Study Design:	Supportive Care, Open Label
Official Title:	A Trial of Carboxypeptidase-G2 (CPDG2) For The Management of Patients With Intrathecal Methotrexate Overdose

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Methotrexate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	10
Study Start Date:	November 1993
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00018967

Show 103 Study Locations

Sponsors and Collaborators

National Cancer Institute (NCI)

Children's Oncology Group

Investigators

Study Chair:	Brigitte C. Widemann, MD	NCI - Pediatric Oncology Branch
Study Chair:	Brigitte C. Widemann, MD	NCI - Pediatric Oncology Branch

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Widemann BC, Balis FM, Shalabi A, Boron M, O'Brien M, Cole DE, Jayaprakash N, Ivy P, Castle V, Muraszko K, Moertel CL, Trueworthy R, Hermann RC, Moussa A, Hinton S, Reaman G, Poplack D, Adamson PC. Treatment of accidental intrathecal methotrexate overdose with intrathecal carboxypeptidase G2. J Natl Cancer Inst. 2004 Oct 20;96(20):1557-9.

Widemann BC, Balis FM, Shalabi A, et al.: Carboxypeptidase-G2 (CPDG2) treatment of accidental intrathecal (IT) methotrexate (MTX) overdose. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-490, 2002.

Study ID Numbers:	CDR0000077521, NCI-92-C-0137N, CCG-0923, POG-9688, NCI-T92-0021N, COG-0923, COG-P9688
Study First Received:	July 11, 2001
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00018967 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Neurotoxicity Syndromes
Antineoplastic Agents
Nervous System Diseases
Physiological Effects of Drugs
Poisoning
Disorders of Environmental Origin
Enzyme Inhibitors

Reproductive Control Agents
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Methotrexate
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 27, 2009