The University of Illinois at Chicago has enrolled the first patient in the United States in a study of a new treatment for the most common and aggressive type of brain tumor.
The international, multi-center trial will compare the best standard treatments -- surgical removal of the tumor, radiotherapy or chemotherapy -- to that treatment combined with a new, noninvasive therapy that provides alternating electrical fields directly to the surface of the head.
"This therapy is a totally novel approach that is, in concept, relatively simple," said Dr. Herbert Engelhard, associate professor of neurosurgery and site investigator for the trial at UIC.
Following a baseline MRI to determine the location of the tumor, several electrodes are placed on the patient's shaved head. The electrodes are connected to a medical device with alternating electric fields powered by a portable battery. The patient remains on the portable device for 22 hours a day, indefinitely, while continuing his or her daily activities at home.
"Research has shown that these electrical fields rupture the cancer cells as they divide," Engelhard said.
While likely not a cure for the deadly tumor, called glioblastoma multiforme, the therapy, Engelhard says, may extend life for some people. In an earlier small-scale study, the therapy more than doubled survival for glioblastoma patients.
Glioblastoma multiforme is the most deadly of all intracranial tumors. Standard therapy does not provide a cure and often results in side effects that compromise a patient's quality of life. Despite attempts to improve outcome, the current three-year survival is only 6 percent.
"Patients with recurrent glioblastoma whose tumor progresses despite radiation treatment and chemotherapy do not have many options," Engelhard said. "Therefore, it's critical that we consider new therapies for the treatment of this disease."
Fifty-one-year-old Daniel Torres of Chicago is a pioneer, according to Engelhard. Torres is the first person in the United States randomized to receive the novel therapy.
On Nov. 15 Torres had 36 electrodes placed on his head to emit very low intensity, intermediate frequency electric fields called tumor-treating fields. He was kept in the hospital overnight for observation and discharged the next day.
Torres, a father of four, ages 6 to 16, says the therapy may offer him a second chance at life. He has had three surgeries, chemotherapy, radiation and radiotherapy since he was first diagnosed with glioblastoma multiforme nearly three years ago.
He says he is hopeful for himself, but also for future patients who may benefit from the study.
The trial will enroll 236 patients at 10 U.S. centers and seven in Europe. Half the patients will receive continuous therapy with the NovoTTF-100A in addition to standard treatment and will be evaluated every four weeks; the other half will receive the standard treatment alone. All patients in the study will be evaluated for disease progression.