Low-dose Temozolomide for 2 Weeks on Brain Tumor Enzyme in Patients With Gliomas (P04602 AM1) (Completed)

Inclusion criteria

• Presence of a brain tumor with high probability of being a glioma as detected by Magnetic Resonance Imaging (MRI). These would include newly diagnosed tumors or potentially recurrent gliomas.
• No prior treatment for the tumor including chemotherapy or radiotherapy.
• Amenable to surgery for biopsy or resection of the brain tumor. Surgically confirmed diagnosis of glioma (glioblastoma multiforme [GBM], anaplastic astrocytoma [AA], anaplastic oligodendroglioma [AO], anaplastic oligoastrocytoma [AOA], astrocytoma [A] or oligodendroglioma [O]) will be

required for patients to be maintained in the study. Those not fulfilling this requirement will be discontinued and will be replaced.

• Use of medically approved contraception in fertile males and females.
• Women with childbearing potential must have a negative urine or serum

pregnancy test (urinary excretion or serum level of beta-Human Chorionic

Gonadotropin [bHCG]) within 72 hours of randomization.

• Karnofsky Performance Status score >= 70%.
• Signed informed consent form

Exclusion criteria

• Prior chemotherapy.
• Prior radiotherapy at the tumor site.
• History of non-compliance to other therapies.
• Inadequate haematological, 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 x 10^9/L;
• Platelets ≤100 x 10^9/L;
• Haemoglobin <90 g/L;
• Serum creatinine ≥1.5 times upper limit of laboratory normal;
• Total serum bilirubin ≥1.5 times upper limit of laboratory normal (ULN);
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.0 ULN;
• Alkaline phosphatase of > 2.5 ULN.
• Known Human Immunodeficiency Virus [HIV] infection.
• 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, which could interfere with oral medication intake (e.g., frequent vomiting, partial bowel obstruction).