Background
The NovoTTF-100A device is currently being tested in an FDA approved Pivotal (Phase III) clinical trial. The device has previously been tested in two European pilot trials. The data from these trials suggest the NovoTTF-100A may increase the length of time before disease progression and increase median overall survival of recurrent or progressive GBM patients.
European Pilot Trial for Recurrent GBM Patients
• Two of ten patients are feeling well and their tumors have not progressed, more than two years after initiating treatment
• One of these two patients has no tumor visible by MRI
• Treated patients doubled the time before disease progression compared to a matched, control group
• Treated patients doubled the median survival time compared to patients receiving GLIADEL in the GLIADEL clinical trial *
• Patients maintained normal daily activities during the trial
Please visit http://www.pnas.org to read more about the pilot trial results.
Side effects
• Unlike chemotherapy or radiation, the NovoTTF-100A does not appear to have significant side effects; Some patients have experienced skin irritation beneath the electrodes
• No device related serious adverse events were observed in over 120 patient-months of cumulative exposure to NovoTTF-100A treatment
FURTHER STUDY REQUIRED TO VALIDATE THESE FINDINGS
*http://www.accessdata.fda.gov/