NCT02338037

Neuropharmacokinetics of Eribulin Mesylate in Treating Patients With Primary or Metastatic Brain Tumors

An Intracerebral Microdialysis Study to Determine the Neuropharmacokinetics of Eribulin in Patients With Brain Tumors

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot trial studies the brain concentration of eribulin mesylate in treating patients with primary or metastatic brain tumors. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Collecting small samples of brain fluids may help determine how well eribulin mesylate concentrates into the brain tumor.

Detailed description

PRIMARY OBJECTIVES: I. To determine the neuropharmacokinetic (nPK) profile of eribulin (eribulin mesylate) using intracerebral microdialysis. SECONDARY OBJECTIVES: I. To compare concentrations of eribulin in tumor (enhancing tissue) and normal brain (non-enhancing tissue) when technically feasible to place two microdialysis catheters in a study patient. II. To describe the intracerebral clinical benefit (defined as stable disease, partial response, or complete response) of eribulin in study patients who continue to be treated with eribulin after completing the microdialysis portion of the study. III. To document the toxicity of eribulin in the cohort of patients. OUTLINE: Patients undergo tumor resection or biopsy and have microdialysis catheter placed on day 0. Beginning at least 24 hours later, patients receive eribulin mesylate intravenously (IV) over 2-5 minutes on day 1. Serial brain fluid samples are collected for approximately 72 hours and the microdialysis catheter is then removed. Beginning at least 2 weeks after tumor resection or biopsy, patients may continue to receive eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.

Conditions

• Metastatic Malignant Neoplasm in the Adult Brain
• Primary Brain Tumor

Interventions

Type	Name	Description
PROCEDURE	Therapeutic Conventional Surgery	Undergo tumor resection
PROCEDURE	Biopsy	Undergo biopsy
DRUG	Eribulin Mesylate	Given IV
PROCEDURE	Microdialysis	Undergo intracerebral microdialysis
OTHER	Pharmacological Study	Correlative studies

Timeline

• Start date: 2015-05-19
• Primary completion: 2017-08-04
• Completion: 2024-03-15
• First posted: 2015-01-14
• Last updated: 2024-03-19

Locations

1 site across 1 country: United States