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Efficacy of Protracted Temozolomide in Patients With Progressive High Grade Glioma

This study has been completed.
ClinicalTrials.gov Identifier:
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.
Information provided by (Responsible Party):
Ufuk ABACIOGLU, Marmara University
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:

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


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

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

Marmara University Hospital
Istanbul, Turkey, 34660
Sponsors and Collaborators
Marmara University
Study Chair: Ufuk ABACIOGLU, MD Marmara University Hospital, Radiation Oncology Department
  More Information

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:
Brain Tumor, Recurrent

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
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
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents