UIMC is a leader in the field of brain tumor research and is committed to providing our patients access to the most innovative treatments and clinical trials. Over four years ago, UIMC became the first hospital in the United States to treat a patient using the NovoTTF device, an entirely new cancer treatment approach. Daniel Torres, a UIMC patient, was able to enroll in a clinical trial to study the device against glioblastoma (GBM) tumors, the most aggressive and deadly form of brain cancer. Mr. Torres testified before the FDA panel to support approval of the device. He talked about his long term survival and his remarkable quality of life on the device.
The FDA has now approved the device for adult patients with glioblastoma brain tumors that have returned after treatment with chemotherapy and other interventions. The FDA approved the device after reviewing results from a recently completed randomized pivotal trial. Patients were treated either with the NovoTTF device (alone) or an effective chemotherapy selected by the physician.
For decades, doctors have treated cancer with three methods: drugs, radiation, or surgery. Novocure’s NovoTTF device represents a fourth approach. “The reason why this is so exciting is that we now have FDA approval of a totally new type of treatment for cancer,” said Dr. Herb Engelhard, an associate professor of neurosurgery at the University of Illinois in Chicago. Engelhard helped conduct the study of NovoTTF but received no compensation from the company. Dr. Engelhard is one of four US doctors (and one of only six worldwide) overseeing the ongoing clinical studies of this product.
NovoTTF patients had comparable overall survival times to chemotherapy patients in the pivotal trial. Notably, the NovoTTF treated group had three complete tumor responses versus zero in the chemotherapy group. Patients treated with the device experienced fewer side effects and avoided the side effects common to chemotherapy, such as fatigue, infections, and GI disorders. The only treatment related side effect of the NovoTTF device was a mild to moderate rash beneath the electrode that was easily treatable with topical creams. NovoTTF patients also reported better quality of life scores compared to chemotherapy patients. “All of us as investigators were skeptical at first, but I have seen the scans and I believe this is killing cancer cells in patients,” Dr. Engelhard said. The research manager in the Department of neurosurgery Karriem Watson, MD, MPH stated that “it is very exciting to be able to offer patients ground breaking advances due to clinical trials and it is even more exciting to see clinical research trials evolve into FDA approved treatment options”.
The NovoTTF is a six-pound device that patients carry with them in a small bag. The device creates a low-intensity, alternating electric field within the tumor that exerts physical forces on electrically charged cellular components, preventing the normal cell division process and causing cell death prior to division. The device creates the field by means of four electrodes which are attached to the patient’s shaved head. The electric fields have little effect on healthy cells because healthy cells in the brain divide at a much slower rate, if at all, compared with cancer cells.
The FDA approved the device specifically for a tumor type known as glioblastoma, the most aggressive form of brain cancer. Five-year survival for the disease is just two percent for patients over 45 years old, according to American Cancer Society. About nineteen thousand people in the U.S. are diagnosed with brain cancer each year, according to the National Cancer Institute. Standard treatment is surgery followed by six weeks of high-dose radiation along with a chemotherapy pill and then additional chemotherapy for at least six months or until the tumor stops responding.
To learn more about additional clinical trials in the Department of Neurosurgery at UIC please contact Karriem Watson, MD, MPH at 312-355-0334 or via email at [email protected]