Tumor Tissue Analysis in Patients Receiving Imatinib Mesylate for Malignant Glioma

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00401024
First received: November 16, 2006
Last updated: July 24, 2010
Last verified: July 2009

November 16, 2006
July 24, 2010
July 2006
June 2009   (final data collection date for primary outcome measure)
Tumor:plasma concentration ratio of imatinib mesylate [ Designated as safety issue: No ]
Tumor:plasma concentration ratio of imatinib mesylate
Complete list of historical versions of study NCT00401024 on ClinicalTrials.gov Archive Site
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Tumor Tissue Analysis in Patients Receiving Imatinib Mesylate for Malignant Glioma
Determination of the In-Tumor-Concentration of Imatinib Mesylate in Malignant Glioma After Oral Administration

RATIONALE: Collecting samples of tumor tissue and blood from patients with cancer to study in the laboratory may help doctors learn how patients respond to treatment.

PURPOSE: This clinical trial is looking at tumor tissue samples from patients receiving imatinib mesylate for malignant glioma to see how much imatinib mesylate is found in the tumor tissue.

OBJECTIVES:

Primary

  • Determine the efficacy, of imatinib mesylate, in terms of achieving a therapeutic tumor:plasma concentration ratio, in patients with primary malignant glioma.

Secondary

  • Correlate tumor grade (low vs high) and/or tumor enhancement on MRI with tumor concentration of this drug in these patients.,

OUTLINE: Patients receive oral imatinib mesylate once daily for 7-12 days. Patients then undergo surgical resection.

Blood and tissue samples are collected at the time of surgery and analyzed for imatinib mesylate concentration.

After completion of study treatment, patients are followed for 7 days.

PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.

Interventional
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Masking: Open Label
Primary Purpose: Treatment
Brain and Central Nervous System Tumors
  • Drug: imatinib mesylate
  • Other: pharmacological study
  • Procedure: conventional surgery
Not Provided
Holdhoff M, Supko JG, Gallia GL, Hann CL, Bonekamp D, Ye X, Cao B, Olivi A, Grossman SA. Intratumoral concentrations of imatinib after oral administration in patients with glioblastoma multiforme. J Neurooncol. 2010 Apr;97(2):241-5. Epub 2009 Sep 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
Not Provided
June 2009   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignant glioma of 1 of the following subtypes:

    • Low-grade glioma
    • Anaplastic astrocytoma
    • Anaplastic oligodendroglioma
    • Glioblastoma multiforme
  • Unifocal disease that is progressive or recurrent after prior radiotherapy and/or chemotherapy
  • Scheduled to undergo surgical resection

    • Able to undergo maximal surgical resection of tumor mass

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100%
  • Mini Mental Status Exam ≥ 15
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Creatinine ≥ 1.7 mg/dL
  • BUN ≤ 2 times upper limit of normal (ULN)
  • Transaminases ≤ 4 times ULN
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment
  • No other medical illness that would preclude study treatment, including any of the following:

    • Serious infection
    • Uncontrolled hypertension
    • Unstable angina pectoris
    • Uncontrolled cardiac dysrhythmia

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from all prior therapy
  • At least 4 weeks since prior investigational drugs
  • No more than 1 prior chemotherapy regimen
  • No concurrent chemotherapy, biologic therapy, or radiotherapy
  • No concurrent medications that may interact with imatinib mesylate or interfere with hepatic cytochrome P450 system
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00401024
CDR0000510133, JHOC-J0623, JHOC-NA_00001201
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Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Stuart A. Grossman, MD Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
July 2009

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