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
  Purpose

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.


Condition Intervention
Brain and Central Nervous System Tumors
Drug: imatinib mesylate
Other: pharmacological study
Procedure: conventional surgery

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Determination of the In-Tumor-Concentration of Imatinib Mesylate in Malignant Glioma After Oral Administration

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Tumor:plasma concentration ratio of imatinib mesylate [ Designated as safety issue: No ]

Estimated Enrollment: 33
Study Start Date: July 2006
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00401024

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Study Chair: Stuart A. Grossman, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00401024     History of Changes
Other Study ID Numbers: CDR0000510133, JHOC-J0623, JHOC-NA_00001201
Study First Received: November 16, 2006
Last Updated: July 24, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adult anaplastic oligodendroglioma
adult oligodendroglioma
adult anaplastic astrocytoma
adult giant cell glioblastoma
adult gliosarcoma
recurrent adult brain tumor
adult brain stem glioma
adult mixed glioma
adult glioblastoma
adult pilocytic astrocytoma
adult diffuse astrocytoma
adult anaplastic ependymoma
adult ependymoma
adult myxopapillary ependymoma
adult subependymoma
adult pineal gland astrocytoma
adult subependymal giant cell astrocytoma

Additional relevant MeSH terms:
Glioma
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014