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	Treatment or Intervention	Phase
Adult Oligodendroglioma Mixed Gliomas	Drug: temozolomide	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years   -   70 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--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

--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

--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

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

Study chairs or principal investigators

Martin J. van Den Bent,  Study Chair,  EORTC Brain Tumor Cooperative Group   

Study ID Numbers:  CDR0000066846; EORTC-26971
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003731
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08