drugset / Trial / NCT00521482

Temozolomide vs. Temozolomide and Thalidomide Treatment in Recurrent Glioblastoma

NCT00521482 ↗

Phase 2 Unknown 40 enrolled University of Zurich
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

EvaluationDrugModalityDoseRoute
Comparator Temozolomide Small molecule 75 mg/m2 —
Comparator Temozolomide Small molecule 200 mg/m2 —
Subject Thalidomide Other / unclassified 200 mg —

Indications