Clinical trial NCT00401024: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: 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
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-11-17
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Tumor:plasma concentration ratio of imatinib mesylate
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Stuart A. Grossman, MD
role: STUDY_CHAIR
References:
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.