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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

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.
  • - Serum creatinin < 1.5-fold upper normal range.
  • - ASAT or ALAT < 3-fold upper normal range unless attributed to anticonvulsants.
  • - Alkaline phosphatase < 3-fold upper normal range.
  • - Women with childbearing potential must have a negative serum pregnancy test ≤14 days prior to study enrollment.
  • - Willingness to apply contraception according to local requirements (as stated in patient information)

    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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00941460
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Prof. Dr. Wolfgang Wick
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Michael Weller, Prof. Dr.
Principal Investigator Affiliation University of Zurich
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, Industry
Overall Status Completed
Countries Austria, Germany, Switzerland
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma
Arms & Interventions

Arms

Experimental: one week on one week off

One week on temozolomide is followed by a week without temozolomide.

Experimental: three weeks on, one week off

Temozolomide is given over 3 weeks, followed by a week without temozolomide.

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Landesnervenklinik Wagner-Jauregg, Linz, Austria

Status

Address

Landesnervenklinik Wagner-Jauregg

Linz, , 4020

Wien, Austria

Status

Address

Medical University Vienna, Department of Internal Medicine I

Wien, , 1090

Charite, Department of Neurosurgery, Berlin, Germany

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Address

Charite, Department of Neurosurgery

Berlin, , 13353

Bochum, Germany

Status

Address

Knappschaftskrankenhaus, Department of Neurology

Bochum, , 44892

Bonn, Germany

Status

Address

University Hospital Bonn, Department of Neurology

Bonn, , 53105

University Hospital Düsseldorf, Düsseldorf, Germany

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Address

University Hospital Düsseldorf

Düsseldorf, , 40001

Frankfurt, Germany

Status

Address

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

Frankfurt, , 60528

University Hospital Freiburg, Freiburg, Germany

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Address

University Hospital Freiburg

Freiburg, , 79106

Heidelberg, Germany

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Address

University Hospital Heidelberg, Department of Neurooncology

Heidelberg, , 69120

Homburg/ Saar, Germany

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Saarland University, Department of Neurosurgery

Homburg/ Saar, , 66421

Klinik für Allgemeine Neurochirurgie, Köln, Germany

Status

Address

Klinik für Allgemeine Neurochirurgie

Köln, , 50937

Klinik und Poliklinik für Neurochirurgie, Leipzig, Germany

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Address

Klinik und Poliklinik für Neurochirurgie

Leipzig, , 04103

Munich, Germany

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Address

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

Munich, , 81377

Regensburg, Germany

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Address

University of Regensburg, Department of Neurology

Regensburg, , 93053

Zurich, CH, Switzerland

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Address

University Hospital Zurich, Department of Neurology

Zurich, CH, 8091

Lausanne, Switzerland

Status

Address

Centre Hospitalier Universitaire Vaudois and University of Lausanne

Lausanne, ,

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