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

NCT05410301 | Withdrawn DMC FDA Device

• 1 other identifier: 202109325
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma; Recurrent Glioblastoma

Outcome Measures

Primary Outcomes (2)

• 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

  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).

  From initiation of therapy through 8 weeks of therapy

• Adverse Events according to CTCAE v5.0

  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

  During the initial 8 weeks of treatment

Study Arms (2)

Patients: sBE device applied during sleep, in combination with Lomustine and Bevacizumab

EXPERIMENTAL

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

Device: Static Magnetic and Electric (sBE) device; Drug: Lomustine; Drug: Bevacizumab

Partners of Patients (who sleep in same bed): sBE

EXPERIMENTAL

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)

Device: Static Magnetic and Electric (sBE) device

Interventions

Static Magnetic and Electric (sBE) device DEVICE

Home-based Static Magnetic and Electric (sBE) device that is slept in

Partners of Patients (who sleep in same bed): sBE; Patients: sBE device applied during sleep, in combination with Lomustine and Bevacizumab

Lomustine DRUG

Chemotherapy drug

Patients: sBE device applied during sleep, in combination with Lomustine and Bevacizumab

Bevacizumab DRUG

Chemotherapy and targeted therapy drug

Patients: sBE device applied during sleep, in combination with Lomustine and Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All participating subjects must meet the following criteria on the screening examination to be eligible to participate in the study:
• Participants must be able to understand and willing to sign a written informed consent document. The study requires authorization for collection, utilization and storage of biological materials (blood, plasma, serum) to be used for research on the effects of sBE on tissues.
• If the participant lives with a partner/spouse and they choose to participate in the study as part of Cohort 2, the partner/spouse must be able to understand and be willing to sign a written informed consent document. If the partner chooses not to participate they will be given specific instructions for sleeping arrangements and not being exposed to sBE therapy.
• Participants must allow the research team to assemble the sBE device in their homes and conduct in-person visits or video conference calls for technical support. Participants must reside within a 100 mile radius of Iowa City. Participants must participate in in-person training of use of the sBE device and understand how to safely use the sBE device, and agree to adhere to use only as instructed in the instruction manual (see Appendix I).
• Participants must be able to adhere to using the sBE device daily for at least 8 hours, adhere to the scheduled visits, and agree to record sBE device usage hours accurately and consistently in a daily diary.
• Participants must be 18 years of age or older on the day of signing the informed consent document.
• Participants must have a Karnofsky Performance Status (KPS) ≥ 60 (see Appendix B).
• Participants must be able to physically operate the sBE device independently or with the assistance of a caretaker (see Appendix I).
• Participants must allow a collection of blood/plasma during scheduled visits where labs will be collected for translational research study purposes.
• Participants must allow the study team to disassemble the sBE device and retrieve static magnetic and electric generating components at the termination of the study. Participants may keep the foam mattress or have it removed by the research team at the time of sBE device disassembly.
• Patients must have histologically confirmed GBM (primary) with unequivocal first progression of disease (confirmed by MRI or CT within 2 weeks of study registration).
• Patients must have previous history of failing temozolamide and radiation with this being the first recurrence after standard of care therapy.
• Patients must have no history of bleeding diathesis, previous intracranial hemmorhage, previous intolerance to lomustine or bevacizimab.
• If the patient has had surgical re-resection of the tumor, the following must be true:
• The surgery must confirm the recurrence, but residual or measurable disease after surgery is not a requirement

You may not qualify if:

• Participants who meet any of the following criteria will not be eligible for admission into the study.
• Previous Therapies
• Previous or current treatment with any investigational electromagnetic field generating devices, including but not limited to the Optune and Voyager devices.
• Definitive radiation therapy within three months before the diagnosis of disease progression. Palliative radiation 4 weeks prior to treatment is allowed.
• Concomitant Medications \& Devices
• Implanted electronic medical device including but not limited to implanted cardiac defibrillator, pacemaker, deep brain stimulator.
• Patients who take enzyme-inducing anti-epileptic drugs (EIAED) must be put on non-EIAED anti-convulsants at least 2 weeks prior to starting the lomustine and bevacizumab.
• Underlying conditions that may interfere with lomustine, bevacizumab, or the investigational sBE device within 6 months prior to study registration. If the medical investigator feels intercurrent illness (ie. Infection) prevents delivery of lomustine and bevacizumab they will be excluded.
• Current or recent use of anti-thrombotics or anti-coagulants including but not limited to the following criteria:
• Use of aspirin \> 325 mg/day or other NSAID with anti-platelet activity within 10 days of the first dose of bevacizumab
• Treatment with dipyramidole, ticlopidine, clopidogrel, or cilostaz within 10 days of first dose of bevacizumab
• Use of full dose anti-coagulants if patient's international normalized ratio (INR) \> 1.5 x upper limit of the normal range (ULN) and activated prothrombin time (aPTT) \> 1.5 x ULN. Use of full dose anti-coagulants is permissible if the INR or aPTT is within therapeutic limits according to the medical standards at UIHC and the patient is stable on the current dose for at least 14 days before starting investigational study.
• Comorbidities
• History of known hypersensitivity to lomustine or bevacizumab formulations or chemical/biological similars, recombinant human antibodies, humanized antibodies, or Chinese hamster ovary cell products.
• Other previous malignancies, unless the patient was treated with curative intent \> 2 years prior to registration and determined to be of low risk for recurrence as determined by the treating investigator, with the exception of well controlled basal cell carcinoma or squamous carcinoma of the skin or cervical cancer in situ.

Sponsors & Collaborators

• Varun Monga, MD: lead
• University of Iowa: collaborator

Study Sites (1)

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Lomustine; Bevacizumab

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Varun Monga, MD

  University of Iowa Hospitals & Clinics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: Cohort 1 - Main study group consisting of patients with rGBM and Cohort 2 - Substudy group consisting of a participating unaffected partners of patients with rGBM

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: June 8, 2022
• Study Start: April 1, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 21, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)