International study tests new treatment for brain tumors
Herbert Engelhard: "Unfortunately, many patients with these aggressive brain tumors do not have many options. The goal is to provide new treatment options, improve survival and hopefully improve their quality of life."
Photo: Kathryn Marchetti
UIC is taking part in an international, multicenter study for patients newly diagnosed with the most common and aggressive type of brain tumor, glioblastoma multiforme, or GBM.
The clinical trial will evaluate the safety and effectiveness of the Novo-TTF, a non-invasive device that disrupts the division of cancer cells in the brain.
The device uses alternating electrical fields called "tumor-treating fields," delivered to the surface of the scalp by insulated electrodes.
"The concept is quite simple," said Herbert Engelhard, associate professor of neurosurgery and site investigator for the trial at UIC.
"The tumor-treating fields cause the quickly growing cancer cells to die instead of dividing. And because brain tumor cells have different electrical properties than healthy cells, the healthy cells are spared from damage."
The study will test treatment using the device in combination with standard-of-care therapy surgical removal of the tumor, radiation and chemotherapy with an oral drug called temozolomide and compared to standard-of-care therapy alone.
Engelhard said that in a pilot study, "early data suggest that this investigational treatment may increase the length of time before disease progression and increase median overall survival in newly diagnosed GBM patients."
After a baseline MRI is used to determine the location of the tumor, physicians place several electrodes on the patient's shaved head. The electrodes are connected to the Novo-TTF medical device powered by a portable battery.
The patient remains on the portable device indefinitely for 22 hours a day while continuing daily activities.
UIC currently has three patients enrolled in the study.
One patient, Gerald Bagnowski of Chicago, said he continues his active lifestyle as a part-time elementary school gym teacher and an avid golfer.
"To me, it was a life-or-death situation, and I felt the study was in my best interest," said Bagnowski, who is married and has three adult sons.
In 2006, in an earlier clinical trial for patients who had recurrent glioblastoma, UIC enrolled the first person in the U.S. who was randomly assigned to receive the novel Novo-TTF therapy, Daniel Torres, who has worn the device for 3-and-a-half years.
About five out of every 100,000 Americans are diagnosed each year with glioblastoma, according to the American Brain Tumor Association. Glioblastoma multiforme is the most deadly of all brain tumors. Standard therapy often does not provide a cure and causes side effects that diminish quality of life.
"Unfortunately, many patients with these aggressive brain tumors do not have many options," said Engelhard. "The goal is to provide new treatment options, improve survival and hopefully improve their quality of life."
While not considered a cure for the deadly brain tumor, the treatment may extend life for some people, said Engelhard, although, the research is in its early stages and the benefit of Novo-TTF for patients with GBM has not yet been established.
The trial will enroll about 280 patients at 12 centers in the U.S. and nine in Europe.
Two-thirds of the patients will receive continuous therapy with the NovoTTF-100A in addition to standard treatment; the other one-third will receive the standard treatment alone. All patients will be evaluated for disease progression.
Funding for the study is provided by NovoCure, Ltd., the manufacturer of Novo-TTF.
For more information about the trial, call 312-355-0334 or 800-597-5970.