drugset / Trial / NCT00941460

Comparison of Two Dosing Regimens of Temozolomide in Patients With Progressive or Recurrent Glioblastoma

NCT00941460 ↗

Phase 2 Completed 105 enrolled Prof. Dr. Wolfgang Wick Essex Pharma GmbH · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

For patients with progressive or recurrent glioblastoma there is no standard therapy. One strategy is re-exposure to temozolomide in a higher dose. This increase in dosing can be done by 2 regimens. Aim of this study is to compare these 2 dosing regimens concerning toxicity. In study arm A patients receive temozolomide for one week, followed by a week without temozolomide. In study arm B patients receive temozolomide for three weeks, followed by a week without temozolomide. The regimen that is less toxic will be selected for further evaluations.

Timeline

Start
2009-09
Primary completion
2013-06
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Temozolomide Small molecule 80 mg/m2 —
Subject Temozolomide Small molecule 120 mg/m2 —

Indications