Ph I 5-day Temozolomide + O6-BG in Treatment of Pts w Recurrent / Progressive GBM

PHASE1CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

February 28, 2005

Primary Completion Date

August 31, 2007

Study Completion Date

July 31, 2008

Conditions
GlioblastomaGliosarcoma
Interventions
DRUG

Temodar and O6-Benzylguanine

"O6-BG 120mg/m2 administered intravenously over 1 hr followed by continuous infusion of O6-BG at 30 mg/m2/day for 5 consecutive days. Every 48 hrs repeat dose of 120 mg/m2 over 1 hr administered for total of 3 doses.~Temodar administered orally, in fasting state within 60 minutes of end of 1st 1-hr infusion of O6-BG \& then every 24 hrs during continuous infusion of O6-BG. Temodar administered on day 1 of treatment cycle \& every 24 hrs thereafter for 5 days with treatment cycles repeated every 28 days.~Pts must fast for minimum of 1 hr prior to administration of each dose of Temodar \& continue fasting 2 hrs after administration of each Temodar dose."

Trial Locations (1)

27710

Duke University Health System, Durham

All Listed Sponsors
collaborator

Schering-Plough

INDUSTRY

collaborator

Keryx / AOI Pharmaceuticals, Inc.

INDUSTRY

lead

Duke University

OTHER

NCT00612989 - Ph I 5-day Temozolomide + O6-BG in Treatment of Pts w Recurrent / Progressive GBM | Biotech Hunter | Biotech Hunter