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

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)