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

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ClinicalTrials.gov Identifier: NCT00018967
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 30, 2015
Sponsor:
Collaborator:
Children's Oncology Group
Information provided by:
National Cancer Institute (NCI)

July 11, 2001
January 27, 2003
April 30, 2015
November 1993
April 2007   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00018967 on ClinicalTrials.gov Archive Site
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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

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.

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.

Interventional
Not Applicable
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • Neurotoxicity
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Unspecified Childhood Solid Tumor, Protocol Specific
Drug: glucarpidase
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
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April 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   Switzerland,   United States
Netherlands,   New Zealand,   Puerto Rico
 
NCT00018967
CDR0000077521
NCI-92-C-0137N
CCG-0923
POG-9688
NCI-T92-0021N
COG-0923
COG-P9688
Not Provided
Not Provided
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National Cancer Institute (NCI)
Children's Oncology Group
Study Chair: Brigitte C. Widemann, MD National Cancer Institute (NCI)
National Cancer Institute (NCI)
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP