Efficacy of Protracted Temozolomide in Patients With Progressive High Grade Glioma

This study has been completed.

Sponsor:

Collaborator:

Schering-Plough

Information provided by (Responsible Party):

Ufuk ABACIOGLU, Marmara University

ClinicalTrials.gov Identifier:

NCT00575887

First received: December 17, 2007

Last updated: November 3, 2013

Last verified: November 2013

History of Changes

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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: Anaplastic Astrocytoma Anaplastic Oligodendroglioma Glioblastoma Glioma Gliosarcoma Oligodendroglioma

U.S. FDA Resources

Further study details as provided by Marmara University:

Primary Outcome Measures:

Progression-free Survival at 6-months [ Time Frame: Until progression ] [ Designated as safety issue: No ]


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


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	December 17, 2007
Results First Received:	November 3, 2013
Last Updated:	November 3, 2013
Health Authority:	Turkey: Ministry of Health

Keywords provided by Marmara University:


Temozolomide Brain Tumor, Recurrent Chemotherapy

Additional relevant MeSH terms:


Temozolomide Alkylating Agents Antineoplastic Agents Antineoplastic Agents, Alkylating	Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

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