Adult Glioblastoma Clinical Trial
Official title:
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 craniotomy or 1 week after biopsy, 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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