A Phase II Trial to Evaluate the Effect of Low Dose Temozolomide (TMZ) for 2 Weeks on Brain Tumor O-6-methylguanine-DNA Methyltransferase (MGMT) Activity in Patients With Gliomas.
- 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
- 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
- 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
- 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).