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Two days a week, Dennis
Gibbons has his head shaved and four electrodes pasted to his scalp, part
of an experimental treatment in Pittsburgh
aimed at destroying the cancer cells in his brain. Gibbons, 56, has
glioblastoma multiforme, an aggressive form of brain cancer that is often
fatal within a few years of diagnosis. He is the nation's second person
to use the battery-operated device as part of a large clinical trial. The
trial will test whether the device, the Novo-TTF, can slow the
progression of the disease. The device delivers low-intensity,
alternating electric fields to the tumor site through the scalp. The
fields interfere with the alignment of certain electrically charged
structures within cancer cells during the cell-division process,
according to NovoCure, the privately held company that produces the device.
While preliminary data suggest that tumor growth may be slowed by the
electrical treatment, healthy cells are unaffected, company officials
said. Patients typically notice only a slight warming of the scalp during
the treatment, said Mike Ambrogi, NovoCure's U.S. general manager. He
noted that patients are encouraged to wear the device as much as
possible. Because good contact with the scalp is required, patients must
have their heads shaved every few days and have a new set of electrodes
applied.
The
device was invented by Dr. Yoram Palti, an Israeli researcher who founded
NovoCure. Company officials believe the technology might eventually be
used to treat other types of cancer. Glioblastoma multiforme "is the
most aggressive primary brain tumor," said Dr. Lara Kunschner,
Gibbons' physician and principal investigator for the local study at Allegheny General Hospital's Allegheny Singer
Research Institute. It is one of the most common malignant brain tumors
in adults, though less common than cancers that have metastasized to the
brain from elsewhere in the body. Patients with glioblastoma multiforme
usually have surgery to remove as much of the tumor as possible, followed
by radiation, chemotherapy or a combination of both, Kunschner said. Overall,
the median survival rate is about one year after diagnosis, she said,
though younger people, those with few neurological impairments and those
who have virtually all of the tumor surgically removed tend to live
longer.
The
current study, a Phase III trial approved by the Food and Drug
Administration, is being conducted at centers in the United States and in Europe.
Plans call for enrolling more than 200 patients by late next year.
Besides
Allegheny General, other U.S. centers currently recruiting patients
include the University of Illinois at Chicago, which treated the first
U.S. patient with the device in the current study; Northwestern
University; the New Jersey Neuroscience Institute; Memorial
Sloan-Kettering Cancer Center; Columbia University Medical Center; the
Cleveland Clinic; the University of Virginia Health System and the
Medical College of Wisconsin.
So
far, Gibbons is the only study patient at Allegheny General using the
device. Kunschner said it is too early to tell if it has had a positive
effect.
More
information is available at www.novocuretrial.com.
In Europa disponibile in Svizzera dal Dr. Roger Stupp colui
che ha promosso il protocollo Stupp (Temodal + radioterapia). Contattare
Silvia Hofer a Silvia.Hofer@....
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