SCH 52365 Phase II Clinical Study in Patients With Newly Diagnosed Glioblastoma Multiforme
- Histopathologically confirmed newly diagnosed glioblastoma multiforme with WHO grade
- Histological diagnosis must be made locally after biopsy or neurosurgical tumor
- 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
- Age: >=18 and <=70 years.
- ECOG performance status <=2.
- Stable, non-increasing dose of corticosteroids over the 14 days prior to treatment
- 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
- The investigator and/or subinvestigator must judge that life expectancy is 12 weeks
- Patients may be included regardless of sex or inpatient/outpatient.
- 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
- 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.