Phase 1 Intrathecal Topotecan for Neoplastic Meningitis

PHASE1CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

October 31, 2005

Primary Completion Date

August 31, 2010

Study Completion Date

December 31, 2010

Conditions
Neoplastic Meningitis
Interventions
DRUG

Topotecan

"Induction (4 weeks): Patients will receive IT topotecan for 5 consecutive days during weeks 1 and 3.~The Induction period is the first 4 weeks of therapy."

DRUG

Topotecan

Consolidation (6 weeks): Patients will receive IT topotecan for 5 consecutive days during weeks 1 and 4. The Consolidation period is 6 weeks in duration. Consolidation begins immediately after completion of the 4th week of Induction.

DRUG

Topotecan

Maintenance (4 weeks for 11 courses): Patients will receive IT topotecan for 5 consecutive days during week 1. Each course of Maintenance is 4 weeks in duration. Maintenance begins immediately after completion of the 6th week of Consolidation.

Trial Locations (1)

77030

Texas Children's Hospital, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Baylor College of Medicine

OTHER

NCT00674674 - Phase 1 Intrathecal Topotecan for Neoplastic Meningitis | Biotech Hunter | Biotech Hunter