Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors
NCT ID: NCT00003731
Last Updated: 2012-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
39 participants
INTERVENTIONAL
1998-12-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients with recurrent oligodendroglial tumors.
Detailed Description
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OUTLINE: This is an open label, multicenter study. Patients receive oral temozolomide on days 1-5. Courses are repeated every 28 days. Treatment continues for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months until disease progression.
PROJECTED ACCRUAL: A total of 15-33 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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temozolomide
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: WHO 0-2 Life expectancy: At least 3 months Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) AST/ALT no greater than 2 times ULN Alkaline phosphatase no greater than 2 times ULN Renal: Creatinine clearance at least 60 mL/min Creatinine no greater than 1.25 times ULN Neurologic: See Disease Characteristics Other: Not pregnant or nursing Fertile patients must use effective contraception No other malignant or nonmalignant diseases interfering with follow-up No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study and follow-up
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: Not specified Other: No other concurrent investigational drugs No other concurrent antitumor agents
18 Years
70 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Martin J. van Den Bent, MD
Role: STUDY_CHAIR
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Locations
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Hopital Universitaire Erasme
Brussels, , Belgium
Academisch Ziekenhuis der Vrije Universiteit Brussel
Brussels, , Belgium
U.Z. Gasthuisberg
Leuven, , Belgium
Centre Hospitalier Regional de Lille
Lille, , France
CHU de la Timone
Marseille, , France
CHU de Nancy - Hopital Neurologique
Nancy, , France
Hopital Pasteur
Nice, , France
Centre Antoine Lacassagne
Nice, , France
Institut Gustave Roussy
Villejuif, , France
Nervenklinik Bamberg
Bamberg, , Germany
Universitaetsklinikum Benjamin Franklin
Berlin, , Germany
Klinikum der Universitat Regensburg
Regensburg, , Germany
Azienda Ospedaliera di Padova
Padova (Padua), , Italy
Istituti Fisioterapici Ospitalieri - Roma
Rome, , Italy
University Medical Center Nijmegen
Nijmegen, , Netherlands
Rotterdam Cancer Institute
Rotterdam, , Netherlands
Academisch Ziekenhuis Utrecht
Utrecht, , Netherlands
Instituto Portugues de Oncologia de Francisco Gentil
Lisbon, , Portugal
Postgraduate Medical Institute
Bratislava, , Slovakia
Kantonspital Aarau
Aarau, , Switzerland
University Hospital
Basel, , Switzerland
Inselspital, Bern
Bern, , Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Western General Hospital
Edinburgh, Scotland, United Kingdom
Countries
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References
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Kouwenhoven MC, Kros JM, French PJ, Biemond-ter Stege EM, Graveland WJ, Taphoorn MJ, Brandes AA, van den Bent MJ. 1p/19q loss within oligodendroglioma is predictive for response to first line temozolomide but not to salvage treatment. Eur J Cancer. 2006 Oct;42(15):2499-503. doi: 10.1016/j.ejca.2006.05.021. Epub 2006 Aug 17.
van den Bent MJ, Taphoorn MJ, Brandes AA, Menten J, Stupp R, Frenay M, Chinot O, Kros JM, van der Rijt CC, Vecht ChJ, Allgeier A, Gorlia T; European Organization for Research and Treatment of Cancer Brain Tumor Group. Phase II study of first-line chemotherapy with temozolomide in recurrent oligodendroglial tumors: the European Organization for Research and Treatment of Cancer Brain Tumor Group Study 26971. J Clin Oncol. 2003 Jul 1;21(13):2525-8. doi: 10.1200/JCO.2003.12.015.
Other Identifiers
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EORTC-26971
Identifier Type: -
Identifier Source: secondary_id
EORTC-26971
Identifier Type: -
Identifier Source: org_study_id