Efficacy of Protracted Temozolomide in Patients With Progressive High Grade Glioma

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Glioblastoma Astrocytoma Brain Diseases Brain Neoplasms Brain Tumor, Recurrent Central Nervous System Diseases Central Nervous System Neoplasms Glioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Oligodendroglioma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Marmara University Hospital

Istanbul, 34660, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Temozolomide

Drug

100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles. Number of cycles: Until progression or unacceptable toxicity

Other names: Temodal, Temodar

Primary outcomes

Progression-free Survival at 6-months

Time frame: Until progression

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Collaborators

Schering-Plough

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2009
First posted: Dec 18, 2007
Registry last updated: Dec 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed