Imatinib Mesylate in Treating Patients With Gliomas

Brain and Central Nervous System Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00039364
• Other study ID #: EORTC-16011-26013
• Secondary ID: EORTC-16011EORTC
• Status: Completed
• Phase: Phase 2
• First received: June 6, 2002
• Last updated: July 23, 2012
• Start date: March 2002

Study information

• Verified date: July 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. primary completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Nervous System Neoplasms

Intervention

Drug:
• imatinib mesylate

Locations

Country	Name	City	State
Austria	Kaiser Franz Josef Hospital	Vienna
Belgium	U.Z. Gasthuisberg	Leuven
France	Centre de Lutte Contre le Cancer, Georges-Francois Leclerc	Dijon
France	CRLCC Nantes - Atlantique	Nantes-Saint Herblain
France	Centre Antoine Lacassagne	Nice
France	Institut Gustave Roussy	Villejuif
Italy	Azienda Ospedaliera di Padova	Padova
Netherlands	Daniel Den Hoed Cancer Center at Erasmus Medical Center	Rotterdam
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
United Kingdom	Beatson Oncology Centre	Glasgow	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Italy,  Netherlands,  Switzerland,  United Kingdom, 

References & Publications (2)

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.

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 s — View Citation