Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00613093 | Ph. II Temozolomide + O6-BG in Treatment of Pts w Temozolomide-Resistant Malignant Glioma | PHASE2 | COMPLETED | 67 | — | — | Oct 1, 2002 | Aug 1, 2008 | Jul 9, 2014 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Patients with glioblastoma multiforme | ACTIVE_COMPARATOR | - |
| Patients with Anaplastic Glioma | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Temodar and O6-Benzylguanine (BG) | DRUG | 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. |
Inclusion Criteria: * Patients have recurrent/progressive Malignant Glioma (MG). Stereotactic biopsy at time of recurrence/progression is only required if radiation-induced necrosis is suspected * Patients have MG resistant to Temodar, which is defined as \> or = to 25 percent increase in tumor gro...