Tumor Tissue Analysis in Patients Receiving Imatinib Mesylate for Malignant Glioma
| Status: | Completed |
|---|---|
| Conditions: | Brain Cancer, Brain Cancer, Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 120 |
| Updated: | 6/30/2018 |
| Start Date: | October 12, 2006 |
| End Date: | November 11, 2008 |
Determination of the In-Tumor-Concentration of Imatinib Mesylate in Malignant Glioma After Oral Administration
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.
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.
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.
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.
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
We found this trial at
1
site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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