Viewing Study NCT00001333



Ignite Creation Date: 2024-05-05 @ 10:00 AM
Last Modification Date: 2024-10-26 @ 9:02 AM
Study NCT ID: NCT00001333
Status: COMPLETED
Last Update Posted: 2008-03-04
First Post: 1999-11-03

Brief Title: Phase I Study of Intrathecal Topotecan
Sponsor: National Cancer Institute NCI
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: Phase I Study of Intrathecal Topotecan
Status: COMPLETED
Status Verified Date: 2000-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
93-C-0085 None None None