Ph. I Temozolomide + O6-BG + Irinotecan in Treatment of Pts w Recurrent / Progressive Cerebral Anaplastic Gliomas

PHASE1CompletedINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

January 31, 2005

Primary Completion Date

January 31, 2007

Study Completion Date

July 31, 2008

Conditions
GlioblastomaGliosarcoma
Interventions
DRUG

Temodar, O6-BG, and Irinotecan

2 separate strata accrued independently: Stratum 1-pts receiving Dilantin, Tegretol or phenobarbital. Stratum 2-pts on anti-convulsants other than Dilantin, Tegretol/phenobarbital/pts not on any anti-convulsants. O6-BG administered intravenously 120mg/m2, over 1hr, prior to administration of Temozolomide on day 1 of 21day cycle. O6-BG administered intravenously 30mg/m2/day, over 48hrs, immediately after completion of CPT-11 infusion on day 1 of 21-day cycle. Temozolomide administered orally 355mg/m2 within 60 mins of end of 1hr O6-BG infusion. Treatment cycles may be repeated every 3wks following dose of Temozolomide from previous cycle. CPT-11 administered intravenously in fasting state over 90mins. CPT-11 infusion will begin 1hr after Temozolomide administration. Initial doses 60mg/m2 for stratum 1 \& 40mg/m2 for stratum2. Treatment cycles repeated every 3 wks following dose of CPT-11 from previous cycle.

Trial Locations (1)

27710

Duke University Health System, Durham

All Listed Sponsors
collaborator

Keryx / AOI Pharmaceuticals, Inc.

INDUSTRY

collaborator

Pharmacia

INDUSTRY

lead

Duke University

OTHER

NCT00612638 - Ph. I Temozolomide + O6-BG + Irinotecan in Treatment of Pts w Recurrent / Progressive Cerebral Anaplastic Gliomas | Biotech Hunter | Biotech Hunter