Phase I Study of Intrathecal Topotecan
The purpose of this study is to determine the qualitative and quantitative toxicity of
intrathecal topotecan, a topoisomerase I inhibitor, in patients with meningeal malignancies
refractory to conventional therapy (radiation therapy and chemotherapy). A safe dose of
topotecan that can be recommended for intrathecal administration in subsequent phase II
studies will be established in a limited dosage escalation schedule. The CSF
pharmacokinetics of intrathecal topotecan will also be studied. Topotecan will be
administered intrathecally on a bi-weekly basis for four to six weeks, followed by weekly
administration for 1 month, twice monthly administration for four months and then monthly IT
administration.
Interventional
Endpoint Classification: Safety Study, Primary Purpose: Treatment
United States: Federal Government
930085
NCT00001333
February 1993
December 2000
Name | Location |
---|---|
National Cancer Institute (NCI) | Bethesda, Maryland 20892 |