Efficacy of Protracted Temozolomide in Patients With Progressive High Grade Glioma

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Marmara University
• Collaborator: Schering-Plough
• Treatments: Dacarbazine; Temozolomide

Criteria

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