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Determination of the In-Tumor-Concentration of Imatinib Mesylate in Malignant Glioma After Oral Administration


N/A
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

Determination of the In-Tumor-Concentration of Imatinib Mesylate in Malignant Glioma After Oral Administration


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor:plasma concentration ratio of imatinib mesylate

Safety Issue:

No

Principal Investigator

Stuart A. Grossman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000510133

NCT ID:

NCT00401024

Start Date:

July 2006

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • 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
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410