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

NCT ID: NCT00941460

Last Updated: 2014-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2013-06-30

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.

Conditions

Glioblastoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

one week on one week off

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

Group Type: EXPERIMENTAL

Temozolomide in both arms

Intervention Type: DRUG

initial dose 120 mg/m2 in arm A

three weeks on, one week off

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

Group Type: EXPERIMENTAL

Temozolomide in both arms

Intervention Type: DRUG

initial dose 80 mg/m2 in arm B

Interventions

Temozolomide in both arms

initial dose 120 mg/m2 in arm A

Intervention Type: DRUG

Temozolomide in both arms

initial dose 80 mg/m2 in arm B

Intervention Type: DRUG

Other Intervention Names

Temodal; Temodal

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Essex Pharma GmbH

INDUSTRY

Sponsor Role: collaborator

Prof. Dr. Wolfgang Wick

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Wolfgang Wick

Coordinating Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michael Weller, Prof. Dr.

Role: STUDY_CHAIR

University of Zurich

Locations

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

Saarland University, Department of Neurosurgery

Homburg/ Saar, , 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

Countries

Austria; Germany; Switzerland

Other Identifiers

2008-006871-60

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ISRCTN68738654

Identifier Type: REGISTRY

Identifier Source: secondary_id

DIRECTOR

Identifier Type: -

Identifier Source: org_study_id