Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors
First Line Chemotherapy With Temozolomide in Recurrent Oligodendroglial Tumors, a Phase II Trial
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients with recurrent oligodendroglial tumors.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
OBJECTIVES: I. Assess the therapeutic activity of temozolomide as first line chemotherapy in patients with recurrent oligodendroglial tumors after radiation therapy. II. Assess the objective response and duration of response of these patients given this treatment. III. Characterize the acute side effects of temozolomide in this patient population.
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.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Bamberg, Alemania, D-96049
- Nervenklinik Bamberg
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Berlin, Alemania, D-12200
- Universitaetsklinikum Benjamin Franklin
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Regensburg, Alemania, DOH-9-3053
- Klinikum der Universität Regensburg
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Brussels, Bélgica, 1070
- Hopital Universitaire Erasme
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Brussels, Bélgica, 1090
- Academisch Ziekenhuis der Vrije Universiteit Brussel
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Leuven, Bélgica, B-3000
- U.Z. Gasthuisberg
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Bratislava, Eslovaquia, 833 03
- Postgraduate Medical Institute
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Lille, Francia, 59037
- Centre Hospitalier Regional de Lille
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Marseille, Francia, 13385
- CHU de la Timone
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Nancy, Francia, 54035
- CHU de Nancy - Hopital Neurologique
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Nice, Francia, 06189
- Centre Antoine Lacassagne
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Nice, Francia, 06002
- Hopital Pasteur
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Villejuif, Francia, F-94805
- Institut Gustave Roussy
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Padova (Padua), Italia, 35128
- Azienda Ospedaliera di Padova
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Rome, Italia, 00161
- Istituti Fisioterapici Ospitalieri - Roma
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Nijmegen, Países Bajos, NL-6252 HB
- University Medical Center Nijmegen
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Rotterdam, Países Bajos, 3075 EA
- Rotterdam Cancer Institute
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Utrecht, Países Bajos, 3508 GA
- Academisch Ziekenhuis Utrecht
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Lisbon, Portugal, 1093
- Instituto Portugues de Oncologia de Francisco Gentil
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Scotland
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Edinburgh, Scotland, Reino Unido, EH4 9NQ
- Western General Hospital
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Aarau, Suiza, 5001
- Kantonspital Aarau
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Basel, Suiza, CH-4031
- University Hospital
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Bern, Suiza, CH-3010
- Inselspital, Bern
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Lausanne, Suiza, CH-1011
- Centre Hospitalier Universitaire Vaudois
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS: Histologically proven oligodendroglioma or oligoastrocytoma with at least 25% oligodendroglial elements Recurrent or progressive disease following radiotherapy At least 3 months since prior radiotherapy Measurable disease by MRI or CT scan Lesion must have a diameter of at least 1 cm No progressive neurological deficits from the present recurrence No new neurological deficits interfering with daily activities No tumor causing midline shift or brain stem compression due to which a rapid deterioration is to be expected in case of no response No signs of increased intracranial pressure No extracranial disease
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
Colaboradores e Investigadores
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- EORTC-26971
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