Efficacy of Protracted Temozolomide in Patients With Progressive High Grade Glioma

Marmara University

Status and phase: Completed; Phase 2

Conditions: Oligodendroglioma; Glioblastoma; Astrocytoma; Brain Tumor, Recurrent

Treatments: Drug: Temozolomide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00575887

MU-RO-2005-1

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Temozolomide