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Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
temozolomide
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult oligodendroglioma, adult mixed glioma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Universitaire Erasme
  • Academisch Ziekenhuis der Vrije Universiteit Brussel
  • U.Z. Gasthuisberg
  • Centre Hospitalier Regional de Lille
  • CHU de la Timone
  • CHU de Nancy - Hopital Neurologique
  • Hopital Pasteur
  • Centre Antoine Lacassagne
  • Institut Gustave Roussy
  • Nervenklinik Bamberg
  • Universitaetsklinikum Benjamin Franklin
  • Klinikum der Universitat Regensburg
  • Azienda Ospedaliera di Padova
  • Istituti Fisioterapici Ospitalieri - Roma
  • University Medical Center Nijmegen
  • Rotterdam Cancer Institute
  • Academisch Ziekenhuis Utrecht
  • Instituto Portugues de Oncologia de Francisco Gentil
  • Postgraduate Medical Institute
  • Kantonspital Aarau
  • University Hospital
  • Inselspital, Bern
  • Centre Hospitalier Universitaire Vaudois
  • Western General Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
September 20, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00003731
Brief Title
Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors
Official Title
First Line Chemotherapy With Temozolomide in Recurrent Oligodendroglial Tumors, a Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
December 1998 (undefined)
Primary Completion Date
January 2001 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
adult oligodendroglioma, adult mixed glioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
temozolomide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin J. van Den Bent, MD
Organizational Affiliation
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Hopital Universitaire Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Academisch Ziekenhuis der Vrije Universiteit Brussel
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Centre Hospitalier Regional de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHU de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
CHU de Nancy - Hopital Neurologique
City
Nancy
ZIP/Postal Code
54035
Country
France
Facility Name
Hopital Pasteur
City
Nice
ZIP/Postal Code
06002
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France
Facility Name
Nervenklinik Bamberg
City
Bamberg
ZIP/Postal Code
D-96049
Country
Germany
Facility Name
Universitaetsklinikum Benjamin Franklin
City
Berlin
ZIP/Postal Code
D-12200
Country
Germany
Facility Name
Klinikum der Universitat Regensburg
City
Regensburg
ZIP/Postal Code
DOH-9-3053
Country
Germany
Facility Name
Azienda Ospedaliera di Padova
City
Padova (Padua)
ZIP/Postal Code
35128
Country
Italy
Facility Name
Istituti Fisioterapici Ospitalieri - Roma
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
University Medical Center Nijmegen
City
Nijmegen
ZIP/Postal Code
NL-6252 HB
Country
Netherlands
Facility Name
Rotterdam Cancer Institute
City
Rotterdam
ZIP/Postal Code
3075 EA
Country
Netherlands
Facility Name
Academisch Ziekenhuis Utrecht
City
Utrecht
ZIP/Postal Code
3508 GA
Country
Netherlands
Facility Name
Instituto Portugues de Oncologia de Francisco Gentil
City
Lisbon
ZIP/Postal Code
1093
Country
Portugal
Facility Name
Postgraduate Medical Institute
City
Bratislava
ZIP/Postal Code
833 03
Country
Slovakia
Facility Name
Kantonspital Aarau
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
Facility Name
University Hospital
City
Basel
ZIP/Postal Code
CH-4031
Country
Switzerland
Facility Name
Inselspital, Bern
City
Bern
ZIP/Postal Code
CH-3010
Country
Switzerland
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
CH-1011
Country
Switzerland
Facility Name
Western General Hospital
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH4 9NQ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
16914310
Citation
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.
Results Reference
background
PubMed Identifier
12829671
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 chemotherapy with temozolomide in recurrent oligodendroglial tumors: the European Organization for Research and Treatment of Cancer Brain Tumor Group Study 26971. J Clin Oncol. 2003 Jul 1;21(13):2525-8. doi: 10.1200/JCO.2003.12.015.
Results Reference
result

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Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors

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