Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
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.
;
Masking: Open Label, Primary Purpose: Supportive Care
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