New York, NY (PRWEB) February 25, 2013
Patients with the most aggressive brain tumors may be treated with a head cap that produces changes in electrical fields, as part of an international clinical trial at the Icahn School of Medicine at Mount Sinai.
The novel portable brain cancer treatment device, the NovoTTF-100A System, uses electricity to disrupt the growth of glioblastomas, a highly invasive and rapidly spreading type of brain tumor. The cap contains insulated electrodes and is connected to a portable power source. Worn on a patient’s scalp, which must be shaved, it produces changing electrical fields around the tumor site—called tumor treating fields (TTF)—that may inhibit cancer cell growth.
Glioblastoma multiforme (GBM) is the most aggressive and most common form of primary brain tumor in the U.S. It affects approximately 10,000 Americans each year, with a median overall survival time from initial diagnosis of 15 months with optimal treatment. The cap, which works with other therapies, is designed to control regrowth of this aggressive disease. Patients may remove the cap to shave the scalp or to shower, and wear them under a baseball cap, wig, or scarf. For recurring tumors, median survival is increased compared to other available treatments. The clinical trial is assessing its use in newly diagnosed GBM.
Isabelle M. Germano, MD, FASC, Director of the Comprehensive Brain Tumor Program at Mount Sinai, is leading a prospective, randomized Phase II trial at Mount Sinai, designed to test the efficacy of the device in combination with temozolomide, an oral medication that also inhibits cell growth in adult patients with newly diagnosed glioblastoma. Patients are enrolled after surgery and radiation therapy with concomitant temozolomide are completed as standard of care.
“A diagnosis of glioblastoma is devastating, with most patients dying one year after diagnosis,” said Dr. Germano, who is also Professor of Neurosurgery, Neurology, and Oncological Sciences; and Co-Director of the Radiosurgery Program at Icahn School of Medicine at Mount Sinai. “Through this clinical trial, we hope to improve outcomes for our patients with glioblastoma by combining modalities of treatment, such as surgery, radiation, oral chemotherapy, and TTF therapy as early as possible in the treatment setting.”
Mount Sinai is one of approximately 40 centers that are expected to enroll an estimated 700 patients collectively in the US and abroad. The trial is expected to run for two years. Further information on the clinical trial and participating clinical centers can be found at http://www.clinicaltrials.gov.
TFF therapy has been shown in in vitro and in vivo studies to slow and reverse tumor growth by inhibiting mitosis, the process by which cells divide and replicate. TFF therapy creates a low intensity, alternating electric field within the tumor that exerts physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death prior to division.
The U.S. Food and Drug Administration (FDA) has approved the NovoTTF-100A System for use as a treatment for patients 22 years of age or older with GBM confirmed through brain imaging and subsequent biopsy, or recurrence in the cerebral region of the brain in patients who have received chemotherapy. The device is currently approved as a monotherapy, and as an alternative to standard medical therapy for recurrent GBM after surgical and radiation options have been followed.
The Comprehensive Brain Tumor Program at Mount Sinai provides state-of-the-art, treatment by specialists who take an interdisciplinary approach to ensure the highest quality of care, including team members from the departments of neurosurgery, neurology, radiation oncology, and rehabilitation medicine. Mount Sinai physicians have pioneered some of the most sophisticated technologies to treat these tumors aggressively. The program aims to improve the quality of life and extend the survival rate of patients with brain tumors through a team approach and individualized patient care.
The Tisch Cancer Institute is a world-class translational cancer institute that has recruited more than 30 acclaimed physicians and researchers specializing in basic research, clinical research, and population science; built outstanding programs in solid tumor oncology; enhanced existing robust programs in hematological malignancies; and advanced the study of cancer immunology and vaccine therapy. The completion of the Leon and Norma Hess Center for Science and Medicine in 2012 is enabling the recruitment of up to 20 additional cancer researchers on two full research floors, with 48,000 square feet of space dedicated to cancer research.
The Tisch Cancer Institute’s Cancer Clinical Trials Office (CCTO) provides the infrastructure and resources required to support patient-based cancer research for the Tisch Cancer Institute at Mount Sinai. The CCTO serves as the central location for cancer protocols and provides a centralized database of protocol-specific data. The CCTO maintains a current list of active protocols and enrollments for use by disease teams and TCI management and reports on the status of open protocols.
To learn more about clinical trials at Mount Sinai, visit http://icahn.mssm.edu/research/clinical-trials.
About The Mount Sinai Medical Center
The Mount Sinai Medical Center encompasses both The Mount Sinai Hospital and Icahn School of Medicine at Mount Sinai. Established in 1968, the Icahn School of Medicine is one of the leading medical schools in the United States, and is noted for innovation in education, biomedical research, clinical care delivery, and local and global community service. It has more than 3,400 faculty in 32 departments and 14 research institutes, and ranks among the top 20 medical schools both in National Institutes of Health (NIH) funding and by U.S. News & World Report.
The Mount Sinai Hospital, founded in 1852, is a 1,171-bed tertiary- and quaternary-care teaching facility and one of the nation's oldest, largest and most-respected voluntary hospitals. In 2012, U.S. News & World Report ranked The Mount Sinai Hospital 14th on its elite Honor Roll of the nation's top hospitals based on reputation, safety, and other patient-care factors. Mount Sinai is one of 12 integrated academic medical centers whose medical school ranks among the top 20 in NIH funding and by U.S. News & World Report and whose hospital is on the U.S. News & World Report Honor Roll. Nearly 60,000 people were treated at Mount Sinai as inpatients last year, and approximately 560,000 outpatient visits took place.