NCT05410301

Golden Halo, Static Magnetic and Electric Field Device, in Recurrent Glioblastoma

Feasibility Study of a Static Magnetic and Electric Field Device in Adults With Recurrent Glioblastoma and Their Partners

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Varun Monga, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective, open label, single-center, early feasibility trial will be conducted to assess the safety and feasibility of a home-based Static Magnetic and Electric (sBE) device applied for 8 hours/day during sleep in adult participants with recurrent glioblastoma (rGBM) at their first relapse.

Detailed description

The purpose of this research study is to test the feasibility of a Static Magnetic and Electric Field (sBE) Device when combined with standard chemotherapy drugs, Lomustine and Bevacizumab, in the treatment of patients with recurrent glioblastoma. The sBE device produces static magnetic (sB) and electric (sE) fields and is to be used 8 hours a day by the patients, during sleep, for 8 weeks, while also receiving standard chemotherapy Lomustine and Bevacizumab. Patients will have visits in clinic every two weeks during the treatment period. The visits will include MRI scans, quality of life assessments, neurological and physical exams, and blood draws. After the sBE treatment period, patients will continue standard chemotherapy with their regular oncologists. Partners of the patients, who sleep in the same beds, will be invited to participate and will be involved in the study procedures except for those intended to monitor the disease. If partners do not agree to participate, they will not be able to sleep in the devices.

Conditions

• Glioblastoma
• Recurrent Glioblastoma

Interventions

Type	Name	Description
DEVICE	Static Magnetic and Electric (sBE) device	Home-based Static Magnetic and Electric (sBE) device that is slept in
DRUG	Lomustine	Chemotherapy drug
DRUG	Bevacizumab	Chemotherapy and targeted therapy drug

Timeline

• Start date: 2023-04-01
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2022-06-08
• Last updated: 2023-04-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study