Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Imatinib Mesylate in Treating Patients With Gliomas

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	Other	EORTC-16011 EORTC-26013, NCT00039364

Objectives

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

Entry Criteria

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

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Neutrophil count at least 2,000/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

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.

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.

Raymond E, Brandes AA, Dittrich C, et al.: 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 26 (28): 4659-65, 2008.[PUBMED Abstract]

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.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Eric Raymond, MD, PhD, Study coordinator		Ph: 33-1-42-11-4289 Email: raymond@igr.fr
Martin van Den Bent, MD, Study coordinator		Ph: 31-10-439-1415 Email: m.vandenbent@erasmusmc.nl

Registry Information
Official Title		Open Label Phase II Study On STI571 (Glivec) Administered As A Daily Oral Treatment In Gliomas
Trial Start Date		2002-03-19
Registered in ClinicalTrials.gov		NCT00039364 1
Date Submitted to PDQ		2002-04-22
Information Last Verified		2002-07-31

Table of Links

1	http://clinicaltrials.gov/ct/show/NCT00039364