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Brief Title: Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors
Official Title: Second Line Chemotherapy With Temozolomide in Recurrent Oligodendroglial Tumors After PCV-Chemotherapy
Study ID: NCT00003304
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 following combination chemotherapy.
Detailed Description: OBJECTIVES: I. Determine the response rate and duration of response in oligodendroglial tumors to temozolomide treatment in patients with progressive disease during or after procarbazine/lomustine/vincristine (PCV) chemotherapy. II. Determine the feasibility and toxicity of temozolomide chemotherapy following PVC chemotherapy in these patients. OUTLINE: This is an open label, multicenter trial. Temozolomide is administered orally on days 1-5 of each 4-week course; treatment continues for a maximum of 12 courses. Patients are followed every 2 months for the first 6 months and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 16-29 patients will be accrued for this study.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Kaiser Franz Josef Hospital, Vienna (Wien), , Austria
Hopital Universitaire Erasme, Brussels, , Belgium
Rigshospitalet, Copenhagen, , Denmark
Helsinki University Central Hospital, Helsinki, , Finland
Turku University Central Hospital, Turku, , Finland
Institut Bergonie, Bordeaux, , France
Centre Regional Francois Baclesse, Caen, , France
Hopital Louis Pasteur, Colmar, , France
Centre Hospitalier Universitaire de Bicetre, Le Kremlin Bicetre, , France
Centre Leon Berard, Lyon, , France
CHU de la Timone, Marseille, , France
CHU de Nancy - Hopital Neurologique, Nancy, , France
CRLCC Nantes - Atlantique, Nantes-Saint Herblain, , France
Hopital Pasteur, Nice, , France
Centre Antoine Lacassagne, Nice, , France
C.H.R. de Nimes - Hopital Caremeau, Nimes, , France
CHU Pitie-Salpetriere, Paris, , France
Institut Gustave Roussy, Villejuif, , France
Universitaetsklinikum Benjamin Franklin, Berlin, , Germany
Neurologische Klinik der Henriettenstiftung, Hannover, , Germany
Universitaetsklinikum Tuebingen, Tuebingen, , Germany
National Institute of Neurosurgery, Budapest, , Hungary
Azienda Ospedaliera di Padova, Padova (Padua), , Italy
Universita Degli Studi di Torino, Torino, , Italy
Academisch Ziekenhuis der Vrije Universiteit, Amsterdam, , Netherlands
Antoni van Leeuwenhoekhuis, Amsterdam, , Netherlands
Academisch Ziekenhuis Groningen, Groningen, , Netherlands
Academisch Ziekenhuis Maastricht, Maastricht, , Netherlands
St. Radboud University Hospital, Nijmegen, , Netherlands
Rotterdam Cancer Institute, Rotterdam, , Netherlands
St. Elisabeth Ziekenhuis, Tilburg, , Netherlands
Dr. Bernard Verbeeten Instituut, Tilburg, , Netherlands
Academisch Ziekenhuis Utrecht, Utrecht, , Netherlands
Instituto Portugues de Oncologia de Francisco Gentil, Lisbon, , Portugal
Umea Universitet, Umea, , Sweden
Western General Hospital, Edinburgh, Scotland, United Kingdom
Beatson Oncology Centre, Glasgow, Scotland, United Kingdom
Name: Martin J. van Den Bent, MD
Affiliation: Daniel Den Hoed Cancer Center at Erasmus Medical Center
Role: STUDY_CHAIR