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. Exclusion Criteria: * Extensively disseminated glioblastoma multiforme. * Severe disorders in the heart, liver, kidney, blood, etc. * Presence of previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-situ of the cervix and non melanoma skin cancer. * Women who are pregnant or lactating. * Women who may be pregnant or who could become pregnant and do not adopt contraception method(s). * Participation in another clinical study within 6 weeks prior to the initiation of administration of temozolomide. * Subjects who the investigator and/or subinvestigator judged inappropriate to participate in the study.