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

Launched by BIOTEX, INC. · Jul 31, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Low-Intensity Oscillatory Magnetic Therapy using a device known as the Oncomagnetic Device for patients who have recently been diagnosed with a type of brain cancer called glioblastoma multiforme (GBM). The trial aims to determine how safe this therapy is and how well it works by gradually increasing the time participants are exposed to the device. If you are at least 18 years old, have had surgery to remove as much of the tumor as possible, and are able to receive standard radiation therapy, you may qualify for this study.

Participants will need to provide consent and will undergo regular MRI scans to monitor their condition. The trial is currently recruiting and is open to all genders. It's important to know that certain conditions, such as having significant infections, specific types of brain tumors, or certain medical devices, may exclude someone from participating. Overall, this trial hopes to find a new way to help patients with GBM and improve their treatment options.

Gender

ALL

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) 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 both 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).