drugset / Trial / NCT00521482
Temozolomide vs. Temozolomide and Thalidomide Treatment in Recurrent Glioblastoma
RandomizedParallel-groupOpen-labelTreatment
Summary
The aim of this study is to evaluate the efficacy and safety of intensive dose temozolomide treatment alone in parallel to a combination with thalidomide in patients with recurrent glioblastoma after standard therapy. In the treatment arm A of the study it will be investigated whether or not continuous dosing of temozolomide may overcome alkylator resistance in patients with glioblastoma who progress on the 5/28 day dosing regimen. For treatment arm B it is postulated that the combination of thalidomide and temozolomide is effective with respect to time to progression and progression-free survival due to the fact that temozolomide and thalidomide have different mechanisms of action.
Timeline
- Start
- 2007-09
- Primary completion
- —
- Completion
- 2009-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Temozolomide | Small molecule | 75 mg/m2 | — |
| Comparator | Temozolomide | Small molecule | 200 mg/m2 | — |
| Subject | Thalidomide | Other / unclassified | 200 mg | — |