Using low-intensity magnetic therapy for newly diagnosed glioblastoma patients

Low-Intensity Oscillatory Magnetic Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme (GBM) - An Exposure-time Escalation Pilot Trial

This study is testing whether a low-intensity magnetic therapy device can safely help people who have just been diagnosed with glioblastoma.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: BioTex, Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 6 sites (Stuttgart, Baden-Wurttemberg and 5 other locations)
• Trial ID: NCT06533163 on ClinicalTrials.gov

What this trial studies

This clinical investigation is a non-randomized, multicenter, open-label pilot trial designed to evaluate the safety and effectiveness of the Oncomagnetic Device in patients with newly diagnosed glioblastoma multiforme (GBM). The study will involve an exposure-time escalation approach, where patients will receive varying durations of treatment to assess the device's performance. Participants must have undergone maximal safe resection and have a confirmed diagnosis of GBM, along with specific eligibility criteria related to their health status and treatment history.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed glioblastoma who have undergone maximal safe resection and meet specific health criteria.

Not a fit: Patients with extensive or multicentric disease, or those with tumors located in the brainstem, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a novel therapeutic option for patients with glioblastoma, potentially improving their outcomes.

How similar studies have performed: While this approach is novel, similar studies exploring magnetic therapies have shown promise, though this specific application is less tested.

Eligibility criteria

Inclusion Criteria:

1. The subject is at least 18 years of age.
2. The subject previously had maximal safe resection (MSR) for glioblastoma (GBM) per the discretion of the investigator and is able to receive standard radiotherapy (unless contraindicated or refused by the subject)
3. The subject has a newly confirmed diagnosis of GBM per WHO classification criteria.
4. The subject has pre-op, post-surgical MRI and RX planning MRI scans available for Investigator review.
5. The subject has a confirmed unmethylated MGMT promoter status.
6. The subject has a KPS ≥ 70.
7. The subject's life expectancy is \>12 weeks.
8. The subject is no longer taking corticosteroids.
9. The subject has signed and dated the consent form.
10. The subject has stated understanding and willingness to comply with all clinical investigation procedures and availability for the duration of the clinical investigation.

Exclusion Criteria:

1. The subject has a tumor in the brainstem, extensive or multicentric disease (e.g. in both hemispheres), or an abnormal regrowth pattern between the post operation MRI and RX planning MRI, suggesting early tumor progression, as determined by the Investigator's discretion.
2. The subject is any of the following: pregnant, planning on becoming pregnant during the investigation, breastfeeding, incarcerated, or enrolled in another clinical investigation.
3. The subject has a severe acute infection, any autoimmune disease, significant congenital anomaly, other co-morbidity, or medical problem or is taking immunosuppressant therapy (except Dexamethasone) within 90 days of anticipated device use for a condition that in the opinion of the Investigator and Sponsor precludes enrollment in the investigation.
4. The subject has had a known focal or generalized seizure after surgery.
5. The subject has implants or any condition preventing the patient from undergoing serial MRI scans.
6. The patient has a skull defect (such as, missing bone with no replacement), bullet fragments or ferrous metals.
7. The subject has an active implanted device (e.g., cardiac pacemakers, Vagus Nerve Stimulation \[VNS\], Deep Brain Stimulation \[DBS\], programmable shunts, etc.).
8. The subject has any of the following lab results:

   * ANC \< 1000 cells/mm3 or \< 1.5 x 10\^9 /L.
   * Platelet count \< 100,000 cells/mm3.
9. The subject has a history of any previous anti-tumor treatment for a brain tumor.
10. The subject is currently being treated or has been treated with other investigational agents/devices that may compromise the results of this investigation (as per discretion of the Investigator).
11. The subject takes any nutritional supplements or alternative medical treatments that may compromise the results of this investigation (this is as per discretion of the Investigator, but any compound with anti-oxidant properties is strongly discouraged).
12. The subject has planned concomitant or adjuvant chemotherapy.

Where this trial is running

Stuttgart, Baden-Wurttemberg and 5 other locations

• Clinical Center Stuttgart — Stuttgart, Baden-Wurttemberg, Germany (Recruiting)
• Technical University of Munich — München, Bavaria, Germany (Recruiting)
• University Hospital Bonn — Bonn, North Rhine-Westphalia, Germany (Recruiting)
• Clinical Center Lünen — Lünen, North Rhine-Westphalia, Germany (Recruiting)
• University Hospital Leipzig — Leipzig, Saxony, Germany (Recruiting)
• Medical Center Mannheim — Mannheim, Germany (Recruiting)

Study contacts

• Principal investigator: Frank Giordano, MD — Universitätsmedizin Mannheim | UMM
• Study coordinator: Ashok Gowda

Conditions Glioblastoma Multiforme