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.