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Tumor Tissue Analysis in Patients Receiving Imatinib Mesylate for Malignant Glioma

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
imatinib mesylate
pharmacological study
conventional surgery
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Imatinib mesylate 600mg orally once a day for seven consecutive days prior to surgery with last dose taken one day prior to surgery

Outcomes

Primary Outcome Measures

Tumor:plasma concentration ratio of imatinib mesylate

Secondary Outcome Measures

Full Information

First Posted
November 16, 2006
Last Updated
June 26, 2018
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00401024
Brief Title
Tumor Tissue Analysis in Patients Receiving Imatinib Mesylate for Malignant Glioma
Official Title
Determination of the In-Tumor-Concentration of Imatinib Mesylate in Malignant Glioma After Oral Administration
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
October 12, 2006 (Actual)
Primary Completion Date
February 4, 2008 (Actual)
Study Completion Date
November 11, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Imatinib mesylate 600mg orally once a day for seven consecutive days prior to surgery with last dose taken one day prior to surgery
Intervention Type
Drug
Intervention Name(s)
imatinib mesylate
Intervention Type
Other
Intervention Name(s)
pharmacological study
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Primary Outcome Measure Information:
Title
Tumor:plasma concentration ratio of imatinib mesylate
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart A. Grossman, MD
Organizational Affiliation
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Official's Role
Study Chair
Facility Information:
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19768386
Citation
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. doi: 10.1007/s11060-009-0008-0. Epub 2009 Sep 19.
Results Reference
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Tumor Tissue Analysis in Patients Receiving Imatinib Mesylate for Malignant Glioma

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