Efficacy of Protracted Temozolomide in Patients With Progressive High Grade Glioma

Phase 2

Completed

• Conditions: Brain Tumor, Recurrent; Glioblastoma; Astrocytoma; Oligodendroglioma
• Interventions: Drug: Temozolomide

• Registration Number: NCT00575887
• Lead Sponsor: Marmara University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2007-12-17
• Study First Submitted QC: 2007-12-17
• Study First Posted: 2007-12-18
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2013-11
• Results First Submitted: 2013-11-03
• Results First Submitted QC: 2013-11-03
• Last Update Submitted: 2013-11-03
• Results First Posted: 2013-12-20
• Last Update Posted: 2013-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Temozolomide	-

Primary Outcome Measures

Name	Time	Method
Progression-free Survival at 6-months	Until progression

Trial Locations

Locations (1)

Marmara University Hospital; 🇹🇷 Istanbul, Turkey