The Effects of Continuous 28-day (28/28) Temozolomide Chemotherapy in Subjects With Recurrent Malignant Glioma Who Have Failed the Conventional 5-day (5/28) Treatment (P04601)

Exclusion Criteria

• •GBM progression during the first 2 months of adjuvant temozolomide (5/28).
• •AA progression during the first 2 months of standard temozolomide therapy (5/28).
• •Chemotherapy for the malignant glioma other than temozolomide.
• •More than one prior course of chemotherapy with temozolomide.
• •Patient evolving from anaplastic glioma to GBM following primary therapy.
• •Patient older than 70 years or who received no conventional chemoradiation regimen.
• •Patient who received radiotherapy for recurrent disease.
• •Patient with metastatic disease.
• •Known human immunodeficiency virus (HIV) infection.
• •History of non-compliance to other therapies.
• •Inadequate hematological, renal and hepatic function according to all of the following laboratory values (to be performed within 14 days, inclusive, prior to study inclusion):
• •Absolute neutrophil count \<=1.5 ×10\^9/L;
• •Platelets \<=100 ×10\^9/L;
• •Hemoglobin \<90 g/L;
• •Serum creatinine \>=1.5 times upper limit of laboratory normal (ULN);
• •Total serum bilirubin \>=1.5 times ULN;
• •ASAT (AST \[aspartate aminotransferase\]) or ALAT (ALT \[alanine aminotransferase) \>2.0 times ULN;
• •Alkaline phosphatase of \>2.5 times ULN.
• •Known chronic hepatitis B or hepatitis C infection.
• •Any other serious medical condition, according to the medical judgment of the physician prior to inclusion in the study.
• •Any medical condition that could interfere with oral medication intake (e.g., frequent vomiting, partial bowel obstruction).
• •Other malignancies during the previous 5 years with the exception of surgically cured carcinoma in-situ of the cervix and basal cell carcinoma or non-melanoma skin cancer.
• •Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule as discussed with the patient before inclusion in the study.