Glioblastoma (GBM) is the most common and most aggressive brain tumor, known to be a highly invasive and rapidly spreading disease. Even with aggressive treatment such as surgery, radiation, and chemotherapy, they are almost always incurable.
The Mount Sinai Comprehensive Brain Tumor Program is pioneering the use of electrical tumor treating fields to be used with conventional therapy. The device, manufactured by Novocure, is called NovoTTF and it is FDA approved for recurrent GBM. It consists of a head cap that produces changes in electrical fields, which is worn continuously.
In a small pilot study, patients with newly diagnosed GBMs who wore the NovoTTF device showed an increase in time before disease progression and showed a possible increase median overall survival rate. The results from this study are now being validated by a larger Phase III clinical trial involving 80 centers around the world, evaluating NovoTTF for newly diagnosed GBM to assess the safety and effectiveness of the device.
The trial, expected to enroll 700 patients total, will test the effectiveness of the NovoTTF used in combination with the oral chemotherapy drug, temozolomide, as compared to temozolomid alone, after radiation with temozolomide is completed. The non-invasive portable device uses four electrodes applied to the scalp, which deliver low-intensity electrical fields to the tumor, which disrupts rapid cell division and slows growth of cancer cells in the brain. The electrodes are connected to a light weight rechargeable battery pack (approx. 6 lbs.). Patients may remove the cap to shower, and may wear it under a baseball hat, wig or scarf. During treatment, patients are able to maintain normal daily activities. On average, patients report wearing the device for 20 hours a day, and despite having to carry the battery pack with them, report an increased quality of life.
The NovoTTF does not have side effects usually found in chemotherapy patients, such as nausea, fatigue and serious infections. The most common side effects reported have been skin irritation beneath the electrodes (16%) and headache (3%.)
Glioblastoma multiforme affects about 10,000 Americans annually. We are excited to be a part of this groundbreaking trial which we think will change the way GMB patients are treated, and will increase their overall outcome and quality of life.
Isabelle M. Germano, MD
Professor of Neurosurgery, Icahn School of Medicine at Mount Sinai