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).