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

SCH 52365 Phase II Clinical Study in Patients With Newly Diagnosed Glioblastoma Multiforme

The purpose of this study is to evaluate the safety of combination therapy of radiotherapy and temozolomide ("concomitant radiotherapy phase"), and then temozolomide monotherapy ("monotherapy phase"), in patients with newly diagnosed glioblastoma multiforme. Progression free survival and response rate will also be calculated.

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.