Trials / Completed
CompletedNCT00001333
Phase I Study of Intrathecal Topotecan
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (planned)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | topotecan |
Timeline
- Start date
- 1993-02-01
- Completion
- 2000-12-01
- First posted
- 2002-12-10
- Last updated
- 2008-03-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00001333. Inclusion in this directory is not an endorsement.