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Brain and Central Nervous System TumorsPhase 2NCT00039364

Imatinib Mesylate in Treating Patients With Gliomas

A Phase 2 study testing imatinib mesylate in people with Brain and Central Nervous System Tumors, run by European Organisation for Research and Treatment of Cancer - EORTC at 10 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain and Central Nervous System Tumors
What is being tested?
imatinib mesylate
How many people
112 participants
Where
10 sitesin 7 countries
Study dates
Mar 2002to Aug 2004
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

10 sites in 7 countries.

10 sites in 7 countries

France4 sites

  • Centre de Lutte Contre le Cancer, Georges-Francois Leclerc

    Dijon, 21079

  • CRLCC Nantes - Atlantique

    Nantes-Saint Herblain, 44805

  • Centre Antoine Lacassagne

    Nice, 06189

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

Austria1 site

  • Kaiser Franz Josef Hospital

    Vienna, A-1100

Other trials in Austria

Belgium1 site

  • U.Z. Gasthuisberg

    Leuven, B-3000

Other trials in Belgium

Italy1 site

  • Azienda Ospedaliera di Padova

    Padova, 35100

Other trials in Italy

Netherlands1 site

  • Daniel Den Hoed Cancer Center at Erasmus Medical Center

    Rotterdam, 3008 AE

Other trials in Netherlands

Switzerland1 site

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, CH-1011

Other trials in Switzerland

United Kingdom1 site

  • Beatson Oncology Centre

    Glasgow, Scotland, G11 6NT

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Being tested
imatinib mesylate
Keywords
recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult mixed glioma, adult pilocytic astrocytoma, adult subependymoma, adult giant cell glioblastoma, adult gliosarcoma, adult diffuse astrocytoma
Medical subject headings
Central Nervous System Neoplasms, Brain Neoplasms, Glioblastoma, Astrocytoma, Oligodendroglioma, Glioma, Glioma, Subependymal, Gliosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • imatinib mesylateDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startMar 2002
  3. Primary completionAug 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00039364
Sponsor's protocol ID
EORTC-16011-26013
Other IDs
EORTC-16011, EORTC-26013
Status last verified
Jul 2012
First submitted
6 Jun 2002
Last updated
24 Jul 2012
Results posted
No

Publications

  • Raymond E, Brandes AA, Dittrich C, Fumoleau P, Coudert B, Clement PM, Frenay M, Rampling R, Stupp R, Kros JM, Heinrich MC, Gorlia T, Lacombe D, van den Bent MJ; European Organisation for Research and Treatment of Cancer Brain Tumor Group Study. Phase II study of imatinib in patients with recurrent gliomas of various histologies: a European Organisation for Research and Treatment of Cancer Brain Tumor Group Study. J Clin Oncol. 2008 Oct 1;26(28):4659-65. doi: 10.1200/JCO.2008.16.9235.

    PubMed 18824712

  • Raymond E, Brandes A, Van Oosterom A, et al.: Multicentre phase II study of imatinib mesylate in patients with recurrent glioblastoma: an EORTC: NDDG/BTG Intergroup study. [Abstract] J Clin Oncol 22 (Suppl 14): A-1501, 2004.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing imatinib mesylate in people with Brain and Central Nervous System Tumors, run by European Organisation for Research and Treatment of Cancer - EORTC at 10 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in France, Austria, Belgium, Italy, Netherlands and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00039364, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2012.

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