Loading clinical trials...

COMPLETEDPHASE2

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

NCT00941460•Prof. Dr. Wolfgang Wick

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Progressive or recurrent glioblastoma documented by MRI no earlier than 180 days after first surgery for glioblastoma and no earlier than 90 days after completion of radiotherapy.
•Histological diagnosis of glioblastoma
•Tissue available for the determination of MGMT promoter methylation in the primary tumor or from the recurrent tumor if a patient undergoes a surgical procedure at recurrence prior to study entry.
•Prior treatment with temozolomide administered concomitantly with radiotherapy and at least for two cycles (5/28) as an adjuvant treatment
•Informed consent
•Age 18-80 years
•Karnofsky performance score \> 50%
•Neutrophil counts \> 1 500/µl
•Platelet counts \> 100 000/µl
•Hemoglobin \> 10 g/dl
+5 more criteria

Exclusion Criteria

•Progressive or recurrent glioblastoma documented by MRI earlier than 180 days after first surgery for glioblastoma and earlier than 90 days after completion of radiotherapy.
•Treatment with any chemotherapy other than temozolomide according to the schedule of the EORTC NCIC trial (Stupp et al. N Engl J Med 2005;352:987-996) except that an adjuvant starting dose of 200 mg/m2 and more than 6 cycles of adjuvant temozolomide are allowed
•Prior systemic or local treatment with DNA-damaging agents, tyrosine kinase inhibitors or anti-angiogenic agents for any cancer
•Allergy to or other intolerability of temozolomide
•Unable to undergo MRI
•Past medical history of diseases with poor prognosis, e.g. severe coronary heart disease, severe diabetes, immune deficiency, residual deficits after stroke, severe mental retardation
•HIV infection
•Pregnancy
•Breast feeding
•Treatment within in any other clinical trial parallel to the treatment phase of the current study

Locations (16)

Landesnervenklinik Wagner-Jauregg

Linz, Austria

Medical University Vienna, Department of Internal Medicine I

Vienna, Austria

Charite, Department of Neurosurgery

Berlin, Germany

Knappschaftskrankenhaus, Department of Neurology

Bochum, Germany

University Hospital Bonn, Department of Neurology

Bonn, Germany

Klinik für Allgemeine Neurochirurgie

Cologne, 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 im Breisgau, Germany

University Hospital Heidelberg, Department of Neurooncology

Heidelberg, Germany

Key Dates

Start Date

September 1, 2009

Primary Completion Date

June 1, 2013

Completion Date

June 1, 2013

Last Updated

August 15, 2014

Enrollment

105

ACTUAL participants

Conditions

Glioblastoma

Interventions

Temozolomide in both arms

DRUG

Temozolomide in both arms

DRUG

Targeted Pediatric High-Grade Glioma Therapy

NCT05839379

High Grade GliomaDiffuse Intrinsic Pontine Glioma+7 more

View study

RECRUITING

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

NCT00083512

Glioblastoma Multiforme

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 15, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Targeted Pediatric High-Grade Glioma Therapy

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma

EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma

Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients With Recurrent Glioblastoma