Temozolomide Phase II Clinical Study in Patients With Newly Diagnosed Glioblastoma Multiforme (Study P04661)(COMPLETED)

Inclusion Criteria

• •Histopathologically confirmed newly diagnosed glioblastoma multiforme with WHO grade IV.
• •Histological diagnosis must be made locally after biopsy or neurosurgical tumor resection.
• •Four or more unstained tissue sections or a paraffin block must be provided to the Pathological Judgment Committee as tissue specimens.
• •Initial surgery/biopsy at diagnosis performed \<=6 weeks (42 days) prior to treatment with temozolomide.
• •Age: \>=18 and \<=70 years.
• •ECOG performance status \<=2.
• •Stable, non-increasing dose of corticosteroids over the 14 days prior to treatment with temozolomide.
• •No prior chemotherapy or radiotherapy.
• •Laboratory test values obtained within 14 days before initiation of administration of temozolomide must satisfy the following criteria:
• •* absolute neutrophil count \>= 1500/mm\^3;
• •* platelet count \>= 100,000/mm\^3;
• •* serum creatinine \<=1.5 times the upper limit of laboratory normal;
• •* total bilirubin \<=1.5 times the upper limit of laboratory normal;
• •* glutamic oxaloacetic transaminase or glutamic pyruvic transaminase \<2.5 times the upper limit of laboratory normal;
• •* alkaline phosphatase \< 2.5 times the upper limit of laboratory normal.
• •Absence of pathological conditions that interfere with taking oral drugs.
• •Contraception during the study period (from informed consent to the day of the last observation/examination of this study) is required in sexually active, potentially fertile patients, regardless of sex, under the supervision of the investigator or sub-investigator.
• •The investigator and/or subinvestigator must judge that life expectancy is 12 weeks or more.
• •Patients may be included regardless of sex or inpatient/outpatient.