Spots Global Cancer Trial Database for Comparison of Two Dosing Regimens of Temozolomide in Patients With Progressive or Recurrent Glioblastoma

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Trial Identification

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

Official Title: 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

Study ID: NCT00941460

Conditions

Glioblastoma

Interventions

Temozolomide in both arms

Study Description

Brief 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.

Detailed Description:

Keywords

progressive or recurrent glioblastoma

temozolomide

dose intensification

comparison of two dosing regimens

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Landesnervenklinik Wagner-Jauregg, Linz, , Austria

Medical University Vienna, Department of Internal Medicine I, Wien, , Austria

Charite, Department of Neurosurgery, Berlin, , Germany

Knappschaftskrankenhaus, Department of Neurology, Bochum, , Germany

University Hospital Bonn, Department of Neurology, Bonn, , Germany

University Hospital Düsseldorf, Düsseldorf, , Germany

Klinikum der Johann-Wolfgang von Goethe-Universität, Dr. Senckenbergisches Institut für Neuroonkologie, Zentrum für Neurologie und Neurochirurgie, Frankfurt, , Germany

University Hospital Freiburg, Freiburg, , Germany

University Hospital Heidelberg, Department of Neurooncology, Heidelberg, , Germany

Saarland University, Department of Neurosurgery, Homburg/ Saar, , Germany

Klinik für Allgemeine Neurochirurgie, Köln, , Germany

Klinik und Poliklinik für Neurochirurgie, Leipzig, , Germany

Ludwig Maximilians University of Munich , Grosshadern Hospital, Department of Neurosurgery, Munich, , Germany

University of Regensburg, Department of Neurology, Regensburg, , Germany

University Hospital Zurich, Department of Neurology, Zurich, CH, Switzerland

Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, , Switzerland