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

National Cancer Institute (NCI)205 个研究点分布在 1 个国家目标入组 10 人开始时间: 1993年11月最近更新: 2015年4月30日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: National Cancer Institute (NCI)
入组人数: 10
试验地点: 205

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
主要目的: Supportive Care
盲法: None

入排标准

性别: All
接受健康志愿者: 否

入选标准

未提供

排除标准

未提供

研究者

发起方

National Cancer Institute (NCI)

申办方类型

Nih

研究点 (205)

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