Spots Global Cancer Trial Database for Bafetinib in Treating Patients With Recurrent High-Grade Glioma or Brain Metastases

Study Description

Brief Summary: 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.

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial