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 |