Ph. II Temozolomide + O6-BG in Treatment of Pts w Temozolomide-Resistant Malignant Glioma

PHASE2CompletedINTERVENTIONAL
Enrollment

67

Participants

Timeline

Start Date

October 31, 2002

Primary Completion Date

March 31, 2006

Study Completion Date

August 31, 2008

Conditions
Glioblastoma MultiformeAnaplastic Glioma
Interventions
DRUG

Temodar and O6-Benzylguanine (BG)

"Objectives of study are to define role of BG in restoring Temodar sensitivity in patients with Temodar-resistant malignant glioma and to further define the toxicity of combination therapy using Temodar + BG. 2 separate strata accrued independently of each other: Stratum 1-patients with glioblastoma multiforme (GBM). Stratum 2-patients with anaplastic glioma (AG).~BG at 120mg/m2 administered intravenously over 1 hour followed immediately by 48-hour infusion at 30mg/m2/24 hours. Temodar 472mg/m2 administered orally, in fasting state, within 60 minutes of end of the 1-hour administration of BG infusion. Treatment cycles may be repeated every 28 days following dose of Temodar from previous cycle."

Trial Locations (1)

27710

Duke University Health System, Durham

Sponsors
All Listed Sponsors
collaborator

Keryx / AOI Pharmaceuticals, Inc.

INDUSTRY

collaborator

National Institutes of Health (NIH)

NIH

lead

Duke University

OTHER

NCT00613093 - Ph. II Temozolomide + O6-BG in Treatment of Pts w Temozolomide-Resistant Malignant Glioma | Biotech Hunter | Biotech Hunter