Golden Halo, Static Magnetic and Electric Field Device, in Recurrent Glioblastoma
- Conditions
- GlioblastomaRecurrent Glioblastoma
- Interventions
- Registration Number
- NCT05410301
- Lead Sponsor
- Varun Monga, MD
- Brief 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients: sBE device applied during sleep, in combination with Lomustine and Bevacizumab Static Magnetic and Electric (sBE) device The sBE device 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: sBE device applied during sleep, in combination with Lomustine and Bevacizumab Lomustine The sBE device is to be used 8 hours a day by the patients, during sleep, for 8 weeks, while also receiving standard chemotherapy Lomustine and Bevacizumab Partners of Patients (who sleep in same bed): sBE Static Magnetic and Electric (sBE) device Up to 12 associated unaffected partners may agree to sleep within the investigational sBE device congruent with the period of exposure of their rGBM partner (8 weeks + possible extension) Patients: sBE device applied during sleep, in combination with Lomustine and Bevacizumab Bevacizumab The sBE device is to be used 8 hours a day by the patients, during sleep, for 8 weeks, while also receiving standard chemotherapy Lomustine and Bevacizumab
- Primary Outcome Measures
Name Time Method Greater than or equal to 80% sBE compliance as determined by device pressor sensors, participant reporting via daily diary, and participant completion of sBE Device Questionnaire From initiation of therapy through 8 weeks of therapy sBE device use will be assessed based on participant compliance. Compliance will be assessed using sensors in the sBE device, self-reporting via a daily diary, and the sBE Device Questionnaire administered approximately every 2 weeks during the initial 8-week sBE administration period (to coincide with a cycle of lomustine or bevacizumab for Cohort 1 participants).
Adverse Events according to CTCAE v5.0 During the initial 8 weeks of treatment Safety of daily treatment with sBE as determined by the absence of Grade 3 adverse events attributable to sBE as outlined by the CTCAE v5.0
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Iowa Hospitals & Clinics
🇺🇸Iowa City, Iowa, United States