Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors

NCT00003304 | Completed Phase 2

• 1 other identifier: EORTC-26972
• Study Type: interventional
• Target: 29
• Locations: 12 countries
• Sites: 37

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.

Conditions

Brain and Central Nervous System Tumors

Keywords

adult oligodendroglioma

Interventions

temozolomide DRUG

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically proven oligodendroglioma or oligoastrocytoma (with at least 25% oligodendroglial elements) Recurrent or progressive disease following both radiotherapy and procarbazine/lomustine/vincristine chemotherapy (or other nitrosoureas-based chemotherapy) Contrast enhancing, measurable disease (at least one lesion measuring at least 1 cm) by CT or MRI required Within 2 weeks prior to study treatment Within 3 days following concurrent surgery for the recurrence Steroid doses stable or decreasing for at least 2 weeks prior to scan No extracranial disease PATIENT CHARACTERISTICS: Age: 18-69 Performance status: WHO 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute 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) Alkaline phosphatase no greater than 2 times ULN AST/ALT no greater than 2 times ULN Renal: Creatinine no greater than 1.25 times ULN Creatinine clearance at least 60 mL/min Other: Not pregnant or lactating Effective contraception required of fertile women No diseases interfering with follow-up PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No more than one prior chemotherapy regimen At least 4 weeks since prior chemotherapy Prior nitrosourea required At least 6 weeks since nitrosourea Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics More than 3 months since radiotherapy Surgery: Not specified Other: No concurrent treatment with other investigational agents or other antitumor agents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (37)

Kaiser Franz Josef Hospital

Vienna (Wien), A-1100, Austria

Location

Hopital Universitaire Erasme

Brussels, 1070, Belgium

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Helsinki University Central Hospital

Helsinki, FIN-0-0029, Finland

Location

Turku University Central Hospital

Turku, FIN-2-0521, Finland

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Centre Regional Francois Baclesse

Caen, 14076, France

Location

Hopital Louis Pasteur

Colmar, 68024, France

Location

Centre Hospitalier Universitaire de Bicetre

Le Kremlin-Bicêtre, 94275, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

CHU de la Timone

Marseille, 13385, France

Location

CHU de Nancy - Hopital Neurologique

Nancy, 54035, France

Location

CRLCC Nantes - Atlantique

Nantes-Saint Herblain, 44805, France

Location

Hopital Pasteur

Nice, 06002, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

C.H.R. de Nimes - Hopital Caremeau

Nîmes, 30000, France

Location

CHU Pitie-Salpetriere

Paris, 75651, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Universitaetsklinikum Benjamin Franklin

Berlin, D-12200, Germany

Location

Neurologische Klinik der Henriettenstiftung

Hanover, D-30559, Germany

Location

Universitaetsklinikum Tuebingen

Tübingen, D-72076, Germany

Location

National Institute of Neurosurgery

Budapest, 1145, Hungary

Location

Azienda Ospedaliera di Padova

Padova (Padua), 35128, Italy

Location

Universita Degli Studi di Torino

Torino, 10126, Italy

Location

Academisch Ziekenhuis der Vrije Universiteit

Amsterdam, 1007 MB, Netherlands

Location

Antoni van Leeuwenhoekhuis

Amsterdam, 1066 CX, Netherlands

Location

Academisch Ziekenhuis Groningen

Groningen, 9713 EZ, Netherlands

Location

Academisch Ziekenhuis Maastricht

Maastricht, 6202 AZ, Netherlands

Location

St. Radboud University Hospital

Nijmegen, 6500 HB, Netherlands

Location

Rotterdam Cancer Institute

Rotterdam, 3075 EA, Netherlands

Location

St. Elisabeth Ziekenhuis

Tilburg, 5022 GC, Netherlands

Location

Dr. Bernard Verbeeten Instituut

Tilburg, 5042 SB, Netherlands

Location

Academisch Ziekenhuis Utrecht

Utrecht, 3508 GA, Netherlands

Location

Instituto Portugues de Oncologia de Francisco Gentil

Lisbon, 1093, Portugal

Location

Umea Universitet

Umeå, S-901 85, Sweden

Location

Western General Hospital

Edinburgh, Scotland, EH4 9NQ, United Kingdom

Location

Beatson Oncology Centre

Glasgow, Scotland, G11 6NT, United Kingdom

Location

Related 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. doi: 10.1016/j.ejca.2006.05.021. Epub 2006 Aug 17.

  PMID: 16914310 BACKGROUND

• van den Bent MJ, Chinot O, Boogerd W, Bravo Marques J, Taphoorn MJ, Kros JM, van der Rijt CC, Vecht CJ, De Beule N, Baron B. Second-line chemotherapy with temozolomide in recurrent oligodendroglioma after PCV (procarbazine, lomustine and vincristine) chemotherapy: EORTC Brain Tumor Group phase II study 26972. Ann Oncol. 2003 Apr;14(4):599-602. doi: 10.1093/annonc/mdg157.

  PMID: 12649108 RESULT

MeSH Terms

Conditions

Central Nervous System Neoplasms; Oligodendroglioma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Martin J. van Den Bent, MD

  Daniel Den Hoed Cancer Center at Erasmus Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: August 26, 2004
• Study Start: April 1, 1998
• Primary Completion: March 1, 2000
• Last Updated: March 6, 2012

Record last verified: 2012-03

Locations

NL (9); DE (3); FR (13); PT (1); SE (1); GB (2); DK (1); BE (1); IT (2); FI (2); HU (1); AU (1)