MedPath

Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors

Phase 2
Completed
Conditions
Brain and Central Nervous System Tumors
Registration Number
NCT00003731
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
39
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 (24)

Institut Gustave Roussy

🇫🇷

Villejuif, France

U.Z. Gasthuisberg

🇧🇪

Leuven, Belgium

Academisch Ziekenhuis Utrecht

🇳🇱

Utrecht, Netherlands

Instituto Portugues de Oncologia de Francisco Gentil

🇵🇹

Lisbon, Portugal

Academisch Ziekenhuis der Vrije Universiteit Brussel

🇧🇪

Brussels, Belgium

Kantonspital Aarau

🇨🇭

Aarau, Switzerland

Centre Hospitalier Universitaire Vaudois

🇨🇭

Lausanne, Switzerland

CHU de la Timone

🇫🇷

Marseille, France

Hopital Universitaire Erasme

🇧🇪

Brussels, Belgium

Centre Hospitalier Regional de Lille

🇫🇷

Lille, France

CHU de Nancy - Hopital Neurologique

🇫🇷

Nancy, France

Centre Antoine Lacassagne

🇫🇷

Nice, France

Hopital Pasteur

🇫🇷

Nice, France

Nervenklinik Bamberg

🇩🇪

Bamberg, Germany

Klinikum der Universitat Regensburg

🇩🇪

Regensburg, Germany

Universitaetsklinikum Benjamin Franklin

🇩🇪

Berlin, 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

Postgraduate Medical Institute

🇸🇰

Bratislava, Slovakia

Inselspital, Bern

🇨🇭

Bern, Switzerland

University Hospital

🇨🇭

Basel, Switzerland

Western General Hospital

🇬🇧

Edinburgh, Scotland, United Kingdom

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