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Brief Title: Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors
Official Title: First Line Chemotherapy With Temozolomide in Recurrent Oligodendroglial Tumors, a Phase II Trial
Study ID: NCT00003731
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Martin J. van Den Bent, MD
Affiliation: Daniel Den Hoed Cancer Center at Erasmus Medical Center
Role: STUDY_CHAIR