Ph I Oral Topotecan and Temozolomide for Patients With Malignant Gliomas

PHASE1CompletedINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

April 30, 2004

Primary Completion Date

September 30, 2009

Study Completion Date

April 30, 2012

Conditions
GlioblastomaGliosarcomaAnaplastic Astrocytoma
Interventions
DRUG

Oral Topotecan and Temodar

"Temozolomide is taken by mouth once day, every day for 5 consecutive days at dose of 200 mg/m2/day.~Oral Topotecan will be taken daily for 5 consecutive days beginning 12-24 hrs after 1st dose of Temozolomide. Dose escalation of Oral Topotecan will be carried out in cohorts of 3 new subjects beginning w dose level 1 @ 0.75 mg/m2/dose."

Trial Locations (1)

27710

Duke University Health System, Durham

Sponsors
All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

collaborator

Schering-Plough

INDUSTRY

lead

Katy Peters

OTHER