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

N/A

Waitlist Available

Research Sponsored by Varun Monga, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during the initial 8 weeks of treatment

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial tests a new device that creates magnetic and electric fields, used while patients sleep. It targets adults whose brain cancer has returned after initial treatment. The device is combined with standard chemotherapy to see if it helps fight the cancer more effectively. The approach aims to suppress the growth of cancer cells.

Eligible Conditions

Solid Tumors
Glioblastoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during the initial 8 weeks of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during the initial 8 weeks of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and during the initial 8 weeks of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Events according to CTCAE v5.0

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

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Patients: sBE device applied during sleep, in combination with Lomustine and BevacizumabExperimental Treatment3 Interventions

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

Group II: Partners of Patients (who sleep in same bed): sBEExperimental Treatment1 Intervention

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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab

FDA approved

Lomustine

FDA approved

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