drugset / Trial / NCT00612989
Ph I 5-day Temozolomide + O6-BG in Treatment of Pts w Recurrent / Progressive GBM
Phase 1
Completed
42 enrolled
Duke University
Keryx / AOI Pharmaceuticals, Inc. · collabSchering-Plough · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Primary objectives To determine maxi tolerated dose of Temodar® in combo w O6-benzylguanine administered for 5 consecutive days in pts w progressive/recurrent GBM To characterize toxicity associated w Temodar® in combo w O6-BG administered for 5 consecutive days in pts w progressive/recurrent GBM To determine Neulasta®-supported MTD defined as the MTD of Temodar® in combo with O6-BG administered for 5 days while receiving Neulasta® once per treatment cycle between days 7 \& 14 in pts w progressive/recurrent GBM To obtain preliminary response rates of Temodar® in combo w O6-BG administered for 5 consecutive days in pts w progressive/recurrent GBM
Timeline
- Start
- 2005-02
- Primary completion
- 2007-08
- Completion
- 2008-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | O6-benzylguanine | Small molecule | 30 mg/m2 | Intravenous |
| Subject | Temozolomide | Small molecule | — | Oral |
| Background | Pegfilgrastim | Protein / enzyme biologic | 6 mg | Subcutaneous |