MedPath

Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors

Phase 2
Completed
Conditions
Brain and Central Nervous System Tumors
Registration Number
NCT00003304
Lead Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
29
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (37)

St. Elisabeth Ziekenhuis

🇳🇱

Tilburg, Netherlands

Turku University Central Hospital

🇫🇮

Turku, Finland

Institut Bergonie

🇫🇷

Bordeaux, France

Hopital Louis Pasteur

🇫🇷

Colmar, France

CHU de Nancy - Hopital Neurologique

🇫🇷

Nancy, France

CRLCC Nantes - Atlantique

🇫🇷

Nantes-Saint Herblain, France

Institut Gustave Roussy

🇫🇷

Villejuif, France

CHU Pitie-Salpetriere

🇫🇷

Paris, France

Universitaetsklinikum Benjamin Franklin

🇩🇪

Berlin, Germany

Azienda Ospedaliera di Padova

🇮🇹

Padova (Padua), Italy

Universita Degli Studi di Torino

🇮🇹

Torino, Italy

Academisch Ziekenhuis Maastricht

🇳🇱

Maastricht, Netherlands

St. Radboud University Hospital

🇳🇱

Nijmegen, Netherlands

Rotterdam Cancer Institute

🇳🇱

Rotterdam, Netherlands

Kaiser Franz Josef Hospital

🇦🇹

Vienna (Wien), Austria

Helsinki University Central Hospital

🇫🇮

Helsinki, Finland

Centre Regional Francois Baclesse

🇫🇷

Caen, France

CHU de la Timone

🇫🇷

Marseille, France

Hopital Universitaire Erasme

🇧🇪

Brussels, Belgium

Hopital Pasteur

🇫🇷

Nice, France

Centre Hospitalier Universitaire de Bicetre

🇫🇷

Le Kremlin Bicetre, France

National Institute of Neurosurgery

🇭🇺

Budapest, Hungary

Universitaetsklinikum Tuebingen

🇩🇪

Tuebingen, Germany

Centre Leon Berard

🇫🇷

Lyon, France

Centre Antoine Lacassagne

🇫🇷

Nice, France

C.H.R. de Nimes - Hopital Caremeau

🇫🇷

Nimes, France

Western General Hospital

🇬🇧

Edinburgh, Scotland, United Kingdom

Rigshospitalet

🇩🇰

Copenhagen, Denmark

Neurologische Klinik der Henriettenstiftung

🇩🇪

Hannover, Germany

Academisch Ziekenhuis der Vrije Universiteit

🇳🇱

Amsterdam, Netherlands

Antoni van Leeuwenhoekhuis

🇳🇱

Amsterdam, Netherlands

Academisch Ziekenhuis Groningen

🇳🇱

Groningen, 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

Beatson Oncology Centre

🇬🇧

Glasgow, Scotland, United Kingdom

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