NCT01234740

Bafetinib in Treating Patients With Recurrent High-Grade Glioma or Brain Metastases

BAFETINIB-P1-GBM-01: A Pilot Study Using Intracerebral Microdialysis to Determine the Neuropharmacokinetics of Bafetinib in Patients With Recurrent Brain Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adult Anaplastic Astrocytoma
• Adult Anaplastic Ependymoma
• Adult Anaplastic Oligodendroglioma
• Adult Giant Cell Glioblastoma
• Adult Glioblastoma
• Adult Gliosarcoma
• Adult Mixed Glioma
• Recurrent Adult Brain Tumor
• Tumors Metastatic to Brain
• Adult Anaplastic Oligoastrocytoma

Interventions

Type	Name	Description
DRUG	bafetinib	Given orally
PROCEDURE	microdialysis	Catheter placed intracerebrally during debulking craniotomy or stereotactic biopsy
OTHER	pharmacological study	Correlative studies
OTHER	liquid chromatography	Correlative studies
OTHER	mass spectrometry	Correlative studies
OTHER	laboratory biomarker analysis	Correlative studies
GENETIC	protein expression analysis	Correlative studies
GENETIC	western blotting	Correlative studies
OTHER	immunohistochemistry staining method	Correlative studies
PROCEDURE	therapeutic conventional surgery	debulking craniotomy

Timeline

• Start date: 2010-12-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2010-11-04
• Last updated: 2018-04-17

Locations

2 sites across 1 country: United States