Carboxypeptidase-G2 in Treating Nervous System Toxic Effects in Patients Given an Overdose of Intrathecal Methotrexate
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About
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.
Full 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.
Enrollment
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Volunteers
Inclusion and exclusion 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
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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