Bafetinib in Treating Patients With Recurrent High-Grade Glioma or Brain Metastases
Status: | Archived |
---|---|
Conditions: | Cancer, Brain Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 7/1/2011 |
Start Date: | December 2010 |
BAFETINIB-P1-GBM-01: A Pilot Study Using Intracerebral Microdialysis to Determine the Neuropharmacokinetics of Bafetinib in Patients With Recurrent Brain Tumors
RATIONALE: Bafetinib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth.
PURPOSE: This clinical trial studies bafetinib in treating patients with recurrent
high-grade glioma or brain metastases.
PRIMARY OBJECTIVES:I. To determine the neuropharmacokinetics (nPK) and systemic levels of
bafetinib in patients with recurrent malignant brain tumors.SECONDARY OBJECTIVES:I. To
investigate the intrapatient variability of nPK parameters as assessed by intracerebral
microdialysis.II. To document the toxicity of bafetinib in this cohort of patients.III. To
describe the response rate, progression-free survival, and overall survival in patients with
malignant brain tumors treated with bafetinib.IV. To assess for the expression of Lyn and
Fyn kinases and phosphorylation status in pre-treatment tumor samples.OUTLINE:Patients
undergo intracerebral microdialysis during debulking craniotomy or stereotactic biopsy.
Beginning 24 hours later, patients receive oral bafetinib twice daily for 1 day. Beginning
at least 2 weeks after surgery, patients continue to receive oral bafetinib twice daily in
the absence of disease progression or unacceptable toxicity.After completion of study
treatment, patients are followed up for 30 days and then every 8 weeks thereafter.
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