Imatinib Mesylate in Treating Patients With Gliomas

July 23, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

Open Label Phase II Study On STI571 (Glivec) Administered As A Daily Oral Treatment In Gliomas

RATIONALE: Imatinib mesylate may interfere with the growth of tumor cells and slow the growth of the tumor.

PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have gliomas.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the therapeutic activity of imatinib mesylate (in terms of objective response and progression-free survival at 6 months) in patients with gliomas.
  • Determine the safety of this drug in these patients.
  • Determine the pharmacokinetics of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to glioma (glioblastoma multiforme vs anaplastic oligodendroglioma or mixed oligoastrocytoma vs anaplastic astrocytoma or recurrent low-grade astrocytoma).

Patients receive oral imatinib mesylate once or twice daily. Treatment repeats every 4 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months for 6 months and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 77 patients (29 patients with glioblastoma multiforme, 24 patients with anaplastic oligodendroglioma or mixed oligoastrocytoma, and 24 patients with anaplastic astrocytoma or recurrent low-grade astrocytoma) will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

112

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, Austria, A-1100
        • Kaiser Franz Josef Hospital
  • Belgium
      • Leuven, Belgium, B-3000
        • U.Z. Gasthuisberg
  • France
      • Dijon, France, 21079
        • Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
      • Nantes-Saint Herblain, France, 44805
        • CRLCC Nantes - Atlantique
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Villejuif, France, F-94805
        • Institut Gustave Roussy
  • Italy
      • Padova, Italy, 35100
        • Azienda Ospedaliera di Padova
  • Netherlands
      • Rotterdam, Netherlands, 3008 AE
        • Daniel Den Hoed Cancer Center at Erasmus Medical Center
  • Switzerland
      • Lausanne, Switzerland, CH-1011
        • Centre Hospitalier Universitaire Vaudois
  • United Kingdom
    • Scotland
      • 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed glioblastoma multiforme

    • Recurrent disease by CT scan or MRI
    • No prior chemotherapy OR
    • No more than 1 prior chemotherapy regimen in adjuvant setting or for recurrent disease OR

  • Histologically or cytologically confirmed anaplastic oligodendroglioma, mixed oligoastrocytoma, anaplastic astrocytoma, or recurrent low-grade astrocytoma

    • Failed prior radiotherapy

    • No more than 1 prior chemotherapy regimen

      • Failed adjuvant chemotherapy OR
      • Failed first-line chemotherapy

  • At least 1 bidimensionally measurable target lesion

    • At least 2 cm on contrast-enhanced CT scan or MRI

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Neutrophil count at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST and ALT no greater than 2.5 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN

Renal:

  • Creatinine less than 1.7 mg/dL

Cardiovascular:

  • Cardiac function normal
  • No ischemic heart disease within the past 6 months
  • Normal 12-lead ECG

Other:

  • No other prior or concurrent malignancy except cone-biopsied carcinoma of the cervix or adequately treated basal cell or squamous cell skin cancer
  • No unstable systemic disease
  • No active uncontrolled infection
  • No psychological, familial, sociological, or geographical condition that would preclude study compliance
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent anticancer biologic agents
  • No concurrent cytokines (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])

Chemotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosourea)
  • No concurrent chemotherapy

Endocrine therapy:

  • Must be on stable or decreasing dose of corticosteroids for at least 2 weeks

Radiotherapy:

  • See Disease Characteristics
  • At least 3 months since prior brain irradiation
  • No prior high-dose radiotherapy (more than 65 Gy), stereotactic radiosurgery, or internal radiotherapy unless the recurrence is histologically confirmed
  • No concurrent radiotherapy

Surgery:

  • Prior surgery for primary brain tumor within the past 3 months allowed provided one of the following conditions are present:

    • Postoperative imaging within 72 hours after surgery shows a clearly limited target lesion of at least 2 cm
    • Postoperative follow-up shows a progressive and measurable target lesion
    • A second measurable target lesion is present outside the surgical area

Other:

  • No concurrent warfarin or other anticoagulants
  • No other concurrent anticancer agents
  • No other concurrent investigational 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

Investigators

  • Study Chair: Eric Raymond, MD, PhD, Gustave Roussy, Cancer Campus, Grand Paris

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

March 1, 2002

Primary Completion (Actual)

August 1, 2004

Study Registration Dates

First Submitted

June 6, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

July 24, 2012

Last Update Submitted That Met QC Criteria

July 23, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-16011-26013
  • EORTC-16011
  • EORTC-26013

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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