The Mount Sinai Comprehensive Brain Tumor Program is currently enrolling patients in the following clinical trials:

Novocure: Newly Diagnosed Glioblastoma Prospective, Multi-Center Trial of Novottf-100A Together with Temozolomide Compared to Temozolomide Alone in Patients with Newly Diagnosed GBM

PI: Isabelle Germano, MD
Email: Isabelle.germano@mountsinai.org
Funding: Novocure Ltd
For More Information: 212-241-9638 or www.novocuretrial.com

This study is designed to test the efficacy of a novel portable brain cancer treatment device, the NovoTTF-100A System 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.

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.

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.