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GlioblastomaNCT05410301

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

A study testing Static Magnetic and Electric (sBE) device, Lomustine and Bevacizumab in people with Glioblastoma and Recurrent Glioblastoma, run by Varun Monga, MD at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma, Recurrent Glioblastoma
What is being tested?
Static Magnetic and Electric (sBE) device, Lomustine and Bevacizumab
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Apr 2023to Aug 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All substudy participants must meet the following criteria on the screening examination to be eligible to participate in the study:
  • Able to understand and willing to sign a written informed consent document.
  • Be the partner/spouse of a patient with rGBM and be cohabitating and sharing a bed with said patient with rGBM.
  • Agree to allow the research team to assemble the sBE device in their homes and conduct in-person visits or video conference calls for technical support.
  • Agree and be able to adhere to using the sBE device daily for at least 8 hours, adhere to the scheduled visits, and agree to record the number of hours using the sBE device accurately and consistently in a daily diary.
  • Agree to getting a blood/plasma collection for translational research study purposes at scheduled visits where blood collections are outlined.
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  • Agree to accompany their partner with rGBM to all clinical visits where feasibility and safety assessments of the sBE device are being conducted.
  • 18 years of age or older on the day of signing the informed consent document.
  • Healthy as determined by screening assessment and the judgement of the principle investigator.
  • Able to physically operate the sBE device according to the provided instruction manual (see Appendix I).
  • Willing to end treatment with the sBE device when their partner with rGBM terminates treatment with the sBE device.
  • Willing to allow the study team to disassemble and retrieve the static magnetic and electric generating components of the sBE device at the termination of the study.
  • WOCBP must agree to use a medical contraceptive method during the 2-month period of using the sBE device and 6 months after the treatment with the sBE device. WOCBP include any female who is not postmenopausal or has not undergone successful surgical sterilization (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy). Women must not be breastfeeding. In general, appropriate methods of preventing pregnancy should be discussed and agreed upon by the investigator and study participant.
  • Acceptable contraception methods may include oral contraceptives, other hormonal contraceptives (implants, an intrauterine device [IUD] or barrier method. If condoms are used as a barrier method, a spermicidal agent should be added as a double barrier protection.
  • Post-menopause and not of child bearing potential is defined as 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with plasma FSH levels > 40 mIU/mL and estradiol < 20 pg/mL.
  • WOCBP must have a negative plasma or urine pregnancy test within 3 days prior to starting treatment with the sBE device.
  • Men must agree to use a reliable method of birth control and to not donate sperm during the treatment period and for at least 6 months after treatment with the sBE device.

Who cannot join

  • 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.
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  • 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.
  • Hemorrhagic or thrombotic events within 6 months prior to study registration including but not limited to history or evidence of inherited bleeding or coagulation disorders, arterial or venous thromboses, history or evidence of stroke or TIAs, pulmonary embolisms, or pulmonary hemorrhage/hemoptysis greater than grade 1 according to the CTCAE v5.0 criteria within 1 month of study registration.
  • Patients with any impairments in cardiac function within 6 months of the start of the study or clinically significant cardiac diseases, including but not limited to MI, severe/unstable angina, serious cardiac arrhythmias requiring medication or implanted devices (e.g. pacemaker or ICD), second/third degree heart block, history of or ongoing pericarditis, congestive heart failure (New York Heart Association functional classification III-IV), cardiomyopathy, congenital long QT syndrome, coronary artery bypass graft, aortic aneurysms requiring surgical intervention or peripheral arterial thromboses, history of hypertensive crisis or hypertensive encephalopathy, uncontrolled hypertension (defined by systolic BP > 150 mmHg and diastolic BP > 100 mmHg).
  • Presence of an active or ongoing infection or serious underlying medical condition including but not limited to chronic liver disease, chronic kidney disease, chronic pulmonary disease, pancreatitis, or any other clinically relevant disease (other than GBM) that in the investigator's opinion would interfere with the study.
  • Psychosocial illness or situations that would interfere with participant compliance to the study requirements.
  • Any major systemic surgery ≤ 2 weeks prior to the initiation of the study.
  • Patients who are pregnant or breastfeeding.
  • Patients with a history of known coagulopathy that increases risk of bleeding or a history of clinically significant hemorrhage within 1 year of study registration.
  • SUBSTUDY PARTICIPANT SELECTION
  • The unaffected partner of the patient with recurrent GBM will be offered the option to participate in the substudy of the feasibility and safety of treatment with a sBE device. The unaffected partner must understand that their decision to participate or not participate in the substudy is completely voluntary and does not in any way impact the ability of their partner with rGBM to participate in the study. The same screening examination and evaluation will be conducted for the unaffected partner as the patient with recurrent GBM and are detailed in Section 10, Study Calendar. Within 2 weeks of registration, all assessments will occur unless otherwise noted. Each substudy participant must be fully informed on all aspects of the study for informed consent. If the unaffected partner wishes to participate in the substudy, the written informed consent must be obtained from the unaffected partner prior to enrollment of both the GBM patient and the unaffected partner.
  • Following registration, any additional laboratory assessments and/or start of medication that may alter tolerance to the prescribed combination of lomustine, bevacizumab and sBE may be used to re-assess eligibility.
  • Clinically relevant history or current presence of severe comorbidities as determined by the principle investigator including but not limited to cardiovascular, neurological, respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, or psychiatric diseases.
  • Previous malignancies, unless the participant was treated with curative intent >2 years prior to registration or determined to be of low risk for recurrence by the primary investigator, with the exception of well controlled basal cell carcinoma or squamous carcinoma of the skin or cervical cancer in situ.
  • Implanted electronic medical device including but not limited to implanted cardiac defibrillator, pacemaker, deep brain stimulator
  • Current or recent (within 4 weeks of before starting use of the sBE device) treatment with any investigational drug(s) or device(s).
  • History of seizures or current use of enzyme-inducing anti-epileptic drugs (EIAED).
  • Any impairments in cardiac function within 6 months of the start of the study or clinically significant cardiac diseases including but not limited to MI, severe/unstable angina, serious cardiac arrhythmias requiring medication or implanted devices (e.g. pacemaker or ICD), second/third degree heart block, history of or ongoing pericarditis, congestive heart failure (New York Heart Association functional classification III-IV), cardiomyopathy, congenital long QT syndrome, coronary artery bypass graft, aortic aneurysms requiring surgical intervention or peripheral arterial thromboses, history of hypertensive crisis or hypertensive encephalopathy, uncontrolled hypertension (defined by systolic BP > 150 mmHg and diastolic BP > 100 mmHg).
  • Presence of an active or ongoing infection or serious underlying medical condition including but not limited to chronic liver disease, chronic kidney disease, chronic pulmonary disease, pancreatitis, or any other clinically relevant disease that in the investigator's opinion would interfere with the study.
  • Psychosocial illness or situations that would interfere with participant compliance to the study requirements.
  • Any major systemic surgery ≤2 weeks prior to the initiation of the study.
  • Pregnant or breastfeeding.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa, 52242

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Static Magnetic and Electric (sBE) device, Lomustine, Bevacizumab
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Static Magnetic and Electric (sBE) deviceDevice

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

  • LomustineDrug

    Chemotherapy drug

  • BevacizumabDrug

    Chemotherapy and targeted therapy drug

Study groups in NCT05410301
Study groupRoleWhat they receive
Patients: sBE device applied during sleep, in combination with Lomustine and BevacizumabExperimentalThe 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
Receives: Device: Static Magnetic and Electric (sBE) device; Drug: Lomustine; Drug: Bevacizumab
Partners of Patients (who sleep in same bed): sBEExperimentalUp 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)
Receives: Device: Static Magnetic and Electric (sBE) device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: From initiation of therapy through 8 weeks of therapy

  2. 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

    Measured: During the initial 8 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2022
  2. Study startApr 2023 (estimated)
  3. Primary completionAug 2026 (estimated)
  4. Study completionAug 2026 (estimated)

Why it stopped: PI leaving institution

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
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
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05410301
Sponsor's protocol ID
202109325
Status last verified
Apr 2023
First submitted
11 May 2022
Last updated
21 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Static Magnetic and Electric (sBE) device, Lomustine and Bevacizumab in people with Glioblastoma and Recurrent Glioblastoma, run by Varun Monga, MD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: From initiation of therapy through 8 weeks of therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05410301.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.

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