Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors

March 5, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

Second Line Chemotherapy With Temozolomide in Recurrent Oligodendroglial Tumors After PCV-Chemotherapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Determine the response rate and duration of response in oligodendroglial tumors to temozolomide treatment in patients with progressive disease during or after procarbazine/lomustine/vincristine (PCV) chemotherapy. II. Determine the feasibility and toxicity of temozolomide chemotherapy following PVC chemotherapy in these patients.

OUTLINE: This is an open label, multicenter trial. Temozolomide is administered orally on days 1-5 of each 4-week course; treatment continues for a maximum of 12 courses. Patients are followed every 2 months for the first 6 months and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 16-29 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Anticipated)

29

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna (Wien), Austria, A-1100
        • Kaiser Franz Josef Hospital
  • Belgium
      • Brussels, Belgium, 1070
        • Hopital Universitaire Erasme
  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet
  • Finland
      • Helsinki, Finland, FIN-0-0029
        • Helsinki University Central Hospital
      • Turku, Finland, FIN-2-0521
        • Turku University Central Hospital
  • France
      • Bordeaux, France, 33076
        • Institut Bergonié
      • Caen, France, 14076
        • Centre Regional Francois Baclesse
      • Colmar, France, 68024
        • Hôpital Louis Pasteur
      • Le Kremlin Bicetre, France, 94275
        • Centre Hospitalier Universitaire de Bicêtre
      • Lyon, France, 69373
        • Centre Leon Berard
      • Marseille, France, 13385
        • CHU de la Timone
      • Nancy, France, 54035
        • CHU de Nancy - Hopital Neurologique
      • Nantes-Saint Herblain, France, 44805
        • CRLCC Nantes - Atlantique
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Nice, France, 06002
        • Hopital PASTEUR
      • Nimes, France, 30000
        • C.H.R. de Nimes - Hopital Caremeau
      • Paris, France, 75651
        • CHU Pitié-Salpêtrière
      • Villejuif, France, F-94805
        • Institut Gustave Roussy
  • Germany
      • Berlin, Germany, D-12200
        • Universitaetsklinikum Benjamin Franklin
      • Hannover, Germany, D-30559
        • Neurologische Klinik der Henriettenstiftung
      • Tuebingen, Germany, D-72076
        • Universitaetsklinikum Tuebingen
  • Hungary
      • Budapest, Hungary, 1145
        • National Institute of Neurosurgery
  • Italy
      • Padova (Padua), Italy, 35128
        • Azienda Ospedaliera di Padova
      • Torino, Italy, 10126
        • Università degli studi di Torino
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Antoni van Leeuwenhoekhuis
      • Amsterdam, Netherlands, 1007 MB
        • Academisch Ziekenhuis der Vrije Universiteit
      • Groningen, Netherlands, 9713 EZ
        • Academisch Ziekenhuis Groningen
      • Maastricht, Netherlands, 6202 AZ
        • Academisch Ziekenhuis Maastricht
      • Nijmegen, Netherlands, 6500 HB
        • St. Radboud University Hospital
      • Rotterdam, Netherlands, 3075 EA
        • Rotterdam Cancer Institute
      • Tilburg, Netherlands, 5022 GC
        • St. Elisabeth Ziekenhuis
      • Tilburg, Netherlands, 5042 SB
        • Dr. Bernard Verbeeten Instituut
      • Utrecht, Netherlands, 3508 GA
        • Academisch Ziekenhuis Utrecht
  • Portugal
      • Lisbon, Portugal, 1093
        • Instituto Portugues de Oncologia de Francisco Gentil
  • Sweden
      • Umea, Sweden, S-901 85
        • Umeå Universitet
  • United Kingdom
    • Scotland
      • Edinburgh, Scotland, United Kingdom, EH4 9NQ
        • Western General Hospital
      • Glasgow, Scotland, United Kingdom, G11 6NT
        • Beatson Oncology Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1998

Primary Completion (Actual)

March 1, 2000

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

August 25, 2004

First Posted (Estimate)

August 26, 2004

Study Record Updates

Last Update Posted (Estimate)

March 6, 2012

Last Update Submitted That Met QC Criteria

March 5, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-26972

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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