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Imatinib Mesylate in Treating Patients With Gliomas
This study is ongoing, but not recruiting participants.
Study NCT00039364   Information provided by National Cancer Institute (NCI)
First Received: June 6, 2002   Last Updated: November 22, 2008   History of Changes

June 6, 2002
November 22, 2008
March 2002
 
 
 
Complete list of historical versions of study NCT00039364 on ClinicalTrials.gov Archive Site
 
 
 
Imatinib Mesylate in Treating Patients With Gliomas
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.

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.

Phase II
Interventional
Treatment
Brain and Central Nervous System Tumors
Drug: imatinib mesylate
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   France,   Italy,   Netherlands,   Switzerland,   United Kingdom
 
NCT00039364
 
CDR0000069377, EORTC-16011, EORTC-26013
European Organization for Research and Treatment of Cancer
 
Investigator: Eric Raymond, MD, PhD Institut Gustave Roussy
Investigator: Martin J. van Den Bent, MD Daniel Den Hoed Cancer Center at Erasmus Medical Center
National Cancer Institute (NCI)
July 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP