Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003731
Recruitment Status : Completed
First Posted : May 20, 2004
Last Update Posted : September 24, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: temozolomide Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Primary Purpose: Treatment
Official Title: First Line Chemotherapy With Temozolomide in Recurrent Oligodendroglial Tumors, a Phase II Trial
Study Start Date : December 1998
Actual Primary Completion Date : January 2001

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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Please refer to this study by its identifier (NCT number): NCT00003731

Hopital Universitaire Erasme
Brussels, Belgium, 1070
Academisch Ziekenhuis der Vrije Universiteit Brussel
Brussels, Belgium, 1090
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Centre Hospitalier Regional de Lille
Lille, France, 59037
CHU de la Timone
Marseille, France, 13385
CHU de Nancy - Hopital Neurologique
Nancy, France, 54035
Hopital Pasteur
Nice, France, 06002
Centre Antoine Lacassagne
Nice, France, 06189
Institut Gustave Roussy
Villejuif, France, F-94805
Nervenklinik Bamberg
Bamberg, Germany, D-96049
Universitaetsklinikum Benjamin Franklin
Berlin, Germany, D-12200
Klinikum der Universitat Regensburg
Regensburg, Germany, DOH-9-3053
Azienda Ospedaliera di Padova
Padova (Padua), Italy, 35128
Istituti Fisioterapici Ospitalieri - Roma
Rome, Italy, 00161
University Medical Center Nijmegen
Nijmegen, Netherlands, NL-6252 HB
Rotterdam Cancer Institute
Rotterdam, Netherlands, 3075 EA
Academisch Ziekenhuis Utrecht
Utrecht, Netherlands, 3508 GA
Instituto Portugues de Oncologia de Francisco Gentil
Lisbon, Portugal, 1093
Postgraduate Medical Institute
Bratislava, Slovakia, 833 03
Kantonspital Aarau
Aarau, Switzerland, 5001
University Hospital
Basel, Switzerland, CH-4031
Inselspital, Bern
Bern, Switzerland, CH-3010
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
United Kingdom
Western General Hospital
Edinburgh, Scotland, United Kingdom, EH4 9NQ
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Study Chair: Martin J. van Den Bent, MD Daniel Den Hoed Cancer Center at Erasmus Medical Center

Publications of Results:
Other Publications:
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00003731     History of Changes
Other Study ID Numbers: EORTC-26971
First Posted: May 20, 2004    Key Record Dates
Last Update Posted: September 24, 2012
Last Verified: September 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
adult oligodendroglioma
adult mixed glioma

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents