Efficacy of Protracted Temozolomide in Patients With Progressive High Grade Glioma
NCT ID: NCT00575887
Last Updated: 2013-12-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
25 participants
INTERVENTIONAL
2006-08-31
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Schering-Plough
INDUSTRY
Marmara University
OTHER
Responsible Party
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Ufuk ABACIOGLU
Assoc. Prof.
Principal Investigators
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Ufuk ABACIOGLU, MD
Role: STUDY_CHAIR
Marmara University Hospital, Radiation Oncology Department
Locations
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Marmara University Hospital
Istanbul, , Turkey (Türkiye)
Countries
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References
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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.
Other Identifiers
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MU-RO-2005-1
Identifier Type: -
Identifier Source: org_study_id