Carboxypeptidase-G2 in Treating Nervous System Toxic Effects in Patients Given an Overdose of Intrathecal Methotrexate
- Conditions
- Unspecified Adult Solid Tumor, Protocol SpecificNeurotoxicityUnspecified Childhood Solid Tumor, Protocol Specific
- Registration Number
- NCT00018967
- Lead Sponsor
- National Cancer Institute (NCI)
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (103)
University of South Alabama Mitchell Cancer Institute
🇺🇸Mobile, Alabama, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Southern California Permanente Medical Group
🇺🇸Downey, California, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Children's Hospital Central California
🇺🇸Madera, California, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
Kaiser Permanente Medical Center - Oakland
🇺🇸Sacramento, California, United States
Children's Hospital and Health Center - San Diego
🇺🇸San Diego, California, United States
Stanford Comprehensive Cancer Center - Stanford
🇺🇸Stanford, California, United States
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