Optune Device for Brain Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Dr. Derek R Hanson, MD - Hackensack, NJ ...

Overseen byDerek Hanson, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Hackensack Meridian Health

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial tests if a device using electric fields, combined with two drugs, can help children with aggressive brain tumors that have returned after treatment. The device stops cancer cells from growing, while the drugs damage the cancer cells and cut off their blood supply. This approach has been tested for many years and is used for various types of cancer, combining electric pulses with chemotherapy drugs to increase their effectiveness.

Eligibility Criteria

This trial is for pediatric patients with recurrent high-grade glioma or ependymoma brain tumors. Participants must have had prior tumor resection and radiation, be able to undergo MRI scans, and have adequate organ function. They should not have serious side effects from previous treatments, implanted electronic devices in the brain, significant bleeding disorders, or be pregnant or breastfeeding.

Inclusion Criteria

I have a brain tumor that can be treated with TTFields despite having cancer spread to my lower brain or spinal cord.

Patients must be enrolled before treatment begins. Treatment must start within 14 days of study enrollment

All clinical and laboratory studies to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated in the eligibility section

+18 more

Exclusion Criteria

I have no allergies to Chinese hamster ovary cell products or human antibodies.

I don't have severe side effects from past cancer treatments.

I agree to use effective birth control during and for 6 months after therapy.

+20 more

Participant Groups

The study tests the safety of using the Optune NovoTTF-200A device alongside chemotherapy in children with specific types of brain tumors. The device delivers electric fields intended to disrupt cancer cell growth while patients also receive standard drug treatment.

1Treatment groups

Experimental Treatment

Group I: Recurrent high grade gliomas and ependymomasExperimental Treatment1 Intervention

Recurrent high-grade glioma and ependamoma patients will receive treatment with the Optune NovoTTF-200A system as monotherapy. Interventions: Device: Optune NovoTTF-200A System Optune NovoTTF-200A System receive treatment with 200kHz for a minimum of 18 hours per day in 28 day cycles combined with Temozolomide and Bevacizumab.