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.