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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Given orally
Catheter placed intracerebrally during debulking craniotomy or stereotactic biopsy
Correlative studies
Correlative studies
Correlative studies
Correlative studies
Correlative studies
Correlative studies
Correlative studies
debulking craniotomy
City of Hope Medical Center
Duarte, California, United States
South Pasadena Cancer Center
South Pasadena, California, United States
Area-under-the-concentration-time-curve (AUC) of bafetinib in dialysate
Time frame: every hour for 24 hours after first dose of bafetinib
Peak concentration (Cmax) of bafetinib in dialysate
Time frame: every hour for 24 hours after first dose of bafetinib
AUC of bafetinib in plasma
Time frame: 1, 2, 3, 4, 6, 8, and 12 hours after the first dose of bafetinib and then 1, 2, 3, 4, 6, 8, and 12 hours after the second dose of bafetinib
Cmax of bafetinib in plasma
Time frame: 1, 2, 3, 4, 6, 8, and 12 hours after the first dose of bafetinib and then 1, 2, 3, 4, 6, 8, and 12 hours after the second dose of bafetinib
Determination of adverse events associated with bafetinib in patient with recurrent malignant brain tumors
Time frame: 30 days after last dose of bafetinib
Response rate in patients with malignant brain tumors treated with bafetinib
Time frame: 30 days after last dose of bafetinib
Progression-free survival in patients with malignant brain tumors treated with bafetinib
Time frame: 1 year after last dose of bafetinib
Overall survival in patients with malignant brain tumors treated with bafetinib
Time frame: 2 years after last dose of bafetinib
Assessment for expression of Lyn and Fyn kinases and phosphorylation status in pre-treatment tumor samples.
Time frame: Pre-treatment tumor samples
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