Efficacy of Protracted Temozolomide in Patients With Progressive High Grade Glioma

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00575887

First Posted: December 18, 2007

Last Update Posted: December 20, 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

Schering-Plough

Information provided by (Responsible Party):

Ufuk ABACIOGLU, Marmara University

Purpose

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.

Condition	Intervention	Phase
Glioblastoma Astrocytoma Oligodendroglioma Brain Tumor, Recurrent	Drug: Temozolomide	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Efficacy of a Protracted Temozolomide Schedule in Patients With Progression After Standard Dose Temozolomide for High-grade Gliomas

Resource links provided by NLM:

Drug Information available for: Temozolomide

Genetic and Rare Diseases Information Center resources: Glioblastoma Glioma Oligodendroglioma Neuroepithelioma

U.S. FDA Resources

Further study details as provided by Ufuk ABACIOGLU, Marmara University:

Primary Outcome Measures:

Progression-free Survival at 6-months [ Time Frame: Until progression ]


Enrollment:	25
Study Start Date:	August 2006
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Temozolomide 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

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00575887

Locations


Turkey
Marmara University Hospital
Istanbul, Turkey, 34660

Sponsors and Collaborators

Marmara University

Schering-Plough

Investigators


Study Chair:	Ufuk ABACIOGLU, MD	Marmara University Hospital, Radiation Oncology Department

More Information

Publications:

Abacioglu U, Caglar HB, Yumuk PF, Akgun Z, Atasoy BM, Sengoz M. Efficacy of protracted dose-dense temozolomide in patients with recurrent high-grade glioma. J Neurooncol. 2011 Jul;103(3):585-93. doi: 10.1007/s11060-010-0423-2. Epub 2010 Sep 29.


Responsible Party:	Ufuk ABACIOGLU, Assoc. Prof., Marmara University
ClinicalTrials.gov Identifier:	NCT00575887 History of Changes
Other Study ID Numbers:	MU-RO-2005-1
First Submitted:	December 17, 2007
First Posted:	December 18, 2007
Results First Submitted:	November 3, 2013
Results First Posted:	December 20, 2013
Last Update Posted:	December 20, 2013
Last Verified:	November 2013

Keywords provided by Ufuk ABACIOGLU, Marmara University:


Temozolomide Brain Tumor, Recurrent Chemotherapy

Additional relevant MeSH terms:


Glioblastoma Brain Neoplasms Astrocytoma Oligodendroglioma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue	Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases Temozolomide Dacarbazine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents

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