Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors

Brain and Central Nervous System Tumors Clinical Trial

Official title:

First Line Chemotherapy With Temozolomide in Recurrent Oligodendroglial Tumors, a Phase II Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003731
• Other study ID #: EORTC-26971
• Secondary ID: EORTC-26971
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: September 20, 2012
• Start date: December 1998

Study information

• Verified date: September 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 39
• Est. primary completion date: January 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Nervous System Neoplasms

Intervention

Drug:
• temozolomide

Locations

Country	Name	City	State
Belgium	Academisch Ziekenhuis der Vrije Universiteit Brussel	Brussels
Belgium	Hopital Universitaire Erasme	Brussels
Belgium	U.Z. Gasthuisberg	Leuven
France	Centre Hospitalier Regional de Lille	Lille
France	CHU de la Timone	Marseille
France	CHU de Nancy - Hopital Neurologique	Nancy
France	Centre Antoine Lacassagne	Nice
France	Hopital Pasteur	Nice
France	Institut Gustave Roussy	Villejuif
Germany	Nervenklinik Bamberg	Bamberg
Germany	Universitaetsklinikum Benjamin Franklin	Berlin
Germany	Klinikum der Universitat Regensburg	Regensburg
Italy	Azienda Ospedaliera di Padova	Padova (Padua)
Italy	Istituti Fisioterapici Ospitalieri - Roma	Rome
Netherlands	University Medical Center Nijmegen	Nijmegen
Netherlands	Rotterdam Cancer Institute	Rotterdam
Netherlands	Academisch Ziekenhuis Utrecht	Utrecht
Portugal	Instituto Portugues de Oncologia de Francisco Gentil	Lisbon
Slovakia	Postgraduate Medical Institute	Bratislava
Switzerland	Kantonspital Aarau	Aarau
Switzerland	University Hospital	Basel
Switzerland	Inselspital, Bern	Bern
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
United Kingdom	Western General Hospital	Edinburgh	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  Netherlands,  Portugal,  Slovakia,  Switzerland,  United Kingdom, 

References & Publications (2)

Kouwenhoven MC, Kros JM, French PJ, Biemond-ter Stege EM, Graveland WJ, Taphoorn MJ, Brandes AA, van den Bent MJ. 1p/19q loss within oligodendroglioma is predictive for response to first line temozolomide but not to salvage treatment. Eur J Cancer. 2006 Oct;42(15):2499-503. Epub 2006 Aug 17. — View Citation

van den Bent MJ, Taphoorn MJ, Brandes AA, Menten J, Stupp R, Frenay M, Chinot O, Kros JM, van der Rijt CC, Vecht ChJ, Allgeier A, Gorlia T; European Organization for Research and Treatment of Cancer Brain Tumor Group. Phase II study of first-line chemothe — View Citation