A Phase 2 Study of O-Benzylguanine (O-BG) and Temozolomide in Patients With Glioblastoma Progressing at Least 3 Months After Completion of Primary Treatment With Radiation Therapy and Temozolomide
- Determine the antitumor activity of O6-benzylguanine and temozolomide in patients with
temozolomide-resistant methylguanine methyltransferase-positive or -negative
glioblastoma multiforme previously treated with radiotherapy.
- Determine, preliminarily, the toxicity of this regimen in these patients.
OUTLINE: Patients receive O6-benzylguanine IV over 1 hour and oral temozolomide once daily
on days 1-5. Treatment repeats every 28 days in the absence of disease progression or
After completion of study treatment, patients are followed periodically for at least 6
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Confirmed best objective tumor response rate (complete or partial response) in patients with methylguanine methyltransferase (MGMT)-positive tumors as assessed by immunohistochemistry (IHC)
Howard A. Fine, MD
NCI - Neuro-Oncology Branch
United States: Food and Drug Administration
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office||Bethesda, Maryland 20892-1182|
|NCI - Neuro-Oncology Branch||Bethesda, Maryland 20892-8200|