Background
The NovoTTF-100A device is currently being tested in an FDA approved Pivotal
(Phase III) clinical trial for newly diagnosed GBM patients. The
device is also being tested in a 236 patient FDA approved Pivotal (Phase
III) clinical trial for recurrent GBM patients that has concluded enrollment
but is ongoing and no results have been reported to date. The device
has previously been tested in two European pilot trials. The data
from these small pilot trials suggest the NovoTTF-100A may increase the
length of time before disease progression and increase median overall survival
of GBM patients.
European Pilot Trial for Newly Diagnosed GBM Patients (as reported in BMC Medical Physics journal article January 2009)
- Ten patients were treated with NovoTTF in combination with temozolomide following radiation therapy
- Median time to disease progression for the NovoTTF patients reported as 155 weeks (versus 31 weeks for historical controls of temozolomide alone)
- Median overall survival of the NovoTTF patients reported as greater than 39 months and increasing with 8 of 10 patients still alive at the time of the report
- Patients maintained normal daily activities during the trial
FURTHER STUDY REQUIRED TO VALIDATE THESE FINDINGS. THE DEVICE HAS NOT YET BEEN PROVEN TO BE SAFE OR EFFECTIVE FOR ANY INDICATION.
Please visit BMC Medical Physics (http://www.biomedcentral.com/1756-6649/9/1) to read more about the pilot trial results.
Side effects
- Unlike chemotherapy or radiation, based on the limited clinical results to date, the NovoTTF-100A does not appear to have significant side effects. Most patients have experienced skin irritation beneath the electrodes.
- No device related serious adverse events were observed in over 400 patient-months of cumulative exposure to NovoTTF-100A treatment
CAUTION. Investigational Device. Limited by U.S. law to INVESTIGATION USE ONLY.