drugset / Trial / NCT00612638
Ph. I Temozolomide + O6-BG + Irinotecan in Treatment of Pts w Recurrent / Progressive Cerebral Anaplastic Gliomas
Phase 1
Completed
96 enrolled
Duke University
Keryx / AOI Pharmaceuticals, Inc. · collabPharmacia · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Objectives: To determine maximum tolerated dose of CPT-11 when administered following Temodar plus O6-benzylguanine To characterize any toxicity associated w combo of CPT-11 + Temodar plus O6-BG To observe pts for clinical antitumor response when treated w combo of CPT-11 + Temodar + O6-BG
Timeline
- Start
- 2005-01
- Primary completion
- 2007-01
- Completion
- 2008-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irinotecan | Small molecule | 40 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 60 mg/m2 | Intravenous |
| Subject | O6-benzylguanine | Small molecule | 30 mg/m2 | Intravenous |
| Subject | Temozolomide | Small molecule | 355 mg/m2 | Oral |