NCT00941460

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

Dose-intensified Rechallenge With Temozolomide, One Week On One Week Off Versus Three Weeks On One Week Off in Patients With Progressive or Recurrent Glioblastoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Prof. Dr. Wolfgang Wick · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
DRUG	Temozolomide in both arms	initial dose 120 mg/m2 in arm A
DRUG	Temozolomide in both arms	initial dose 80 mg/m2 in arm B

Timeline

• Start date: 2009-09-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2009-07-17
• Last updated: 2014-08-15

Locations

16 sites across 3 countries: Austria, Germany, Switzerland