Imatinib Mesylate in Treating Patients With Gliomas

NCT00039364 | Completed Phase 2

• 3 other identifiers: EORTC-16011-26013EORTC-16011EORTC-26013
• Study Type: interventional
• Target: 112
• Locations: 7 countries
• Sites: 10

Brief 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.

Conditions

Brain and Central Nervous System Tumors

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

Interventions

imatinib mesylate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (10)

Kaiser Franz Josef Hospital

Vienna, A-1100, Austria

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Centre de Lutte Contre le Cancer, Georges-Francois Leclerc

Dijon, 21079, France

Location

CRLCC Nantes - Atlantique

Nantes-Saint Herblain, 44805, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Azienda Ospedaliera di Padova

Padua, 35100, Italy

Location

Daniel Den Hoed Cancer Center at Erasmus Medical Center

Rotterdam, 3008 AE, Netherlands

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Beatson Oncology Centre

Glasgow, Scotland, G11 6NT, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 18824712 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Central Nervous System Neoplasms; Brain Neoplasms; Glioblastoma; Astrocytoma; Oligodendroglioma; Glioma; Glioma, Subependymal; Gliosarcoma

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Ependymoma

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Eric Raymond, MD, PhD

  Gustave Roussy, Cancer Campus, Grand Paris

  STUDY CHAIR

• Martin J. van Den Bent, MD

  Daniel Den Hoed Cancer Center at Erasmus Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2002
• First Posted: January 27, 2003
• Study Start: March 1, 2002
• Primary Completion: August 1, 2004
• Last Updated: July 24, 2012

Record last verified: 2012-07

Locations

CH (1); GB (1); AU (1); IT (1); FR (4); BE (1); NL (1)