Harvey Cushing Brain Tumor Institute Launches Clinical Trial to Explore New Experimental Noninvasive Device to Treat Advanced Brain Tumors
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Researchers at the Brain Tumor Institute of the Harvey Cushing Institutes of Neuroscience are recruiting patients to participate in a multinational, Phase 3 clinical trial for patients with recurrent glioblastoma multiforme – the most common and aggressive type of primary brain tumor. This clinical trial will compare a non-invasive medical device by treating cancer with electric fields, to the best standard of care currently available for recurrent glioblastoma patients. “Participants will have received the best worldwide standard of care, which includes surgery, radiation and chemotherapy,” said Michael Schulder, MD, director of the Harvey Cushing Brain Tumor Institute and vice chairman of neurosurgery at North Shore University Hospital. “Patients with recurrent glioblastoma have few treatment choices today and the non-invasive device that uses tumor treating fields, or TTF, could represent an important new option.” Cancer cells divide rapidly in the brain as opposed to normal brain cells, which practically speaking do not divide. By applying electrical fields across the area of the tumor, the Novo-TTF’s electric fields cause dividing cells to break apart and die without affecting healthy cells. The data from a pilot study of Novo-TTF suggest that the device may increase the length of time before disease progression and may increase median overall survival of recurrent or progressive glioblastoma patients. The non-invasive device creates electrical fields using insulated electrodes placed on a patient’s scalp. The electrodes, which look like bandages, are attached by wires to a portable battery pack. Patients carry the battery pack in a specialized shoulder bag. This makes it possible for patients to receive continuous treatment without changing their daily routine. Funding for the study is provided by NovoCure, Ltd, that developed the Novo-TTF. Clinical Trial Design Eligible patients must be over the age of 18, have glioblastoma that has progressed or recurred after surgery or radiation, and be able to reasonably carry on with normal daily activity. The clinical trial plan is to enroll 236 patients in the US and Europe. NovoCure will pay for costs associated with the clinical trial that are not covered under standard insurance, including the cost for the device, accessories, and more frequent exams. For more information about the clinical trial or to participate, contact Pamela Kribs, RN, research coordinator at the Harvey Cushing Brain Tumor Institute at 516-562-3058, Manhasset, NY. For more information about the Novo-TTF and the clinical trial visit www.novocuretrial.com. About the Harvey Cushing Brain Tumor Institute The Harvey Cushing Brain Tumor Institute, part of the North Shore-LIJ Health System’s Harvey Cushing Institutes of Neuroscience, is a multidisciplinary team aimed at combining basic science, research, clinical programs, surgical techniques, neurooncology and education to advance the care of brain tumors. The Cushing Institutes is a major initiative that creates a continuum of neuroscience programs and evolving neuroscience institutes in the following areas: Chiari malformation and syringomyelia, neurovascular diseases and stroke, movement disorders, brain and spinal cord tumors, diseases of the spine, neuromuscular and peripheral nerve diseases, neurodegenerative diseases, pain, epilepsy, neurological disease of infancy and childhood; neuro-regeneration and neuro-rehabilitation. Each institute is organized as a multidisciplinary, disease-focused center of excellence in the clinical and investigative sciences.
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