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Efficacy of Protracted Temozolomide in Patients With Progressive High Grade Glioma

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ClinicalTrials.gov Identifier: NCT00575887
Recruitment Status : Completed
First Posted : December 18, 2007
Results First Posted : December 20, 2013
Last Update Posted : December 20, 2013
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Ufuk ABACIOGLU, Marmara University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Glioblastoma Astrocytoma Oligodendroglioma Brain Tumor, Recurrent Drug: Temozolomide Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
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
Study Start Date : August 2006
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free Survival at 6-months [ Time Frame: Until progression ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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Publications of Results:

Responsible Party: Ufuk ABACIOGLU, Assoc. Prof., Marmara University
ClinicalTrials.gov Identifier: NCT00575887     History of Changes
Other Study ID Numbers: MU-RO-2005-1
First Posted: December 18, 2007    Key Record Dates
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