Efficacy of Protracted Temozolomide in Patients With Progressive High Grade Glioma

Efficacy of a Protracted Temozolomide Schedule in Patients With Progression After Standard Dose Temozolomide for High-grade Gliomas

The purpose of this study is to evaluate the efficacy of temozolomide on a protracted schedule, after standard 5-day temozolomide regimen in patients with recurrent or progressive high grade glioma.

Inclusion Criteria:

• Patient age >18 years old
• Histopathological diagnosis of high grade glioma (anaplastic astrocytoma or anaplastic oligodendroglioma or anaplastic oligoastrocytoma or glioblastoma multiforme)
• Progression after standard dose (D1-5/28 days)temozolomide either during recurrence or adjuvant treatment approved in Magnetic Resonance imaging
• Karnofsky Performance Status scale >/=50 (due to brain pathology)
• Adequate hematological, renal and hepatic function
• Patients willing to participate in the study and signing the informed consent

Exclusion Criteria:

• Karnofsky Performance Status scale <50
• Female patients with pregnancy or with suspicion of pregnancy. Patients with fertility will be warned for appropriate contraception during the study
• Patients not suitable for follow-up