67
Participants
Start Date
October 31, 2002
Primary Completion Date
March 31, 2006
Study Completion Date
August 31, 2008
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."
Duke University Health System, Durham
Lead Sponsor
Collaborators (1)
Keryx / AOI Pharmaceuticals, Inc.
INDUSTRY
National Institutes of Health (NIH)
NIH
Duke University
OTHER