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

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

This study has been completed.

Study NCT00018967. Last updated on October 18, 2008. Information provided by National Cancer Institute (NCI)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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

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.

Study Phase

Study Type ^†

Interventional

Study Design ^†

Supportive Care, Open Label

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Cancer-Related Problem/Condition
Unspecified Adult Solid Tumor, Protocol Specific
Unspecified Childhood Solid Tumor, Protocol Specific

Intervention ^†

Drug: glucarpidase

MEDLINE PMIDs

15494606

Links

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

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

November 1993

Completion Date

Eligibility 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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Australia, Canada, Switzerland

Administrative Information Fields

NCT ID ^†

NCT00018967

Organization ID

CDR0000077521

Secondary IDs ^††

NCI-92-C-0137N, CCG-0923, POG-9688, NCI-T92-0021N, COG-0923, COG-P9688

Study Sponsor ^†

NCI - Center for Cancer Research-Medical Oncology

Collaborators ^††

National Cancer Institute (NCI)
Children's Oncology Group

Investigators ^†

Study Chair:

Brigitte C. Widemann, MD

NCI - Pediatric Oncology Branch

Information Provided By

National Cancer Institute (NCI)

Verification Date

April 2007

First Received Date ^†

July 11, 2001

Last Updated Date

October 18, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.