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Tumor Tissue Analysis in Patients Receiving Imatinib Mesylate for Malignant Glioma

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ClinicalTrials.gov Identifier: NCT00401024
Recruitment Status : Completed
First Posted : November 17, 2006
Last Update Posted : June 28, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:

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 or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: imatinib mesylate Other: pharmacological study Procedure: conventional surgery Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Determination of the In-Tumor-Concentration of Imatinib Mesylate in Malignant Glioma After Oral Administration
Actual Study Start Date : October 12, 2006
Actual Primary Completion Date : February 4, 2008
Actual Study Completion Date : November 11, 2008


Arm Intervention/treatment
Experimental: Treatment
Imatinib mesylate 600mg orally once a day for seven consecutive days prior to surgery with last dose taken one day prior to surgery
Drug: imatinib mesylate
Other: pharmacological study
Procedure: conventional surgery



Primary Outcome Measures :
  1. Tumor:plasma concentration ratio of imatinib mesylate [ Time Frame: 2 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 at Johns Hopkins
National Cancer Institute (NCI)
Investigators
Study Chair: Stuart A. Grossman, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Publications of Results:
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00401024     History of Changes
Other Study ID Numbers: J0623
P30CA006973 ( U.S. NIH Grant/Contract )
CDR0000510133
NA_00001201 ( Other Identifier: JHM IRB )
First Posted: November 17, 2006    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
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 Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action