Sara to Ed:
The results cited in the `clinical experience' section of clinical trials with the NovoTTF-100A device do look promising, and it is quite positive that the side effects are so minimal. The treatment does not seem to be so toxic to healthy cells, and dermatitis at the electrode's site does not seem to be so bad compared to the side effects of radiation and chemotherapy.
The text indicates that the clinical trial is for glioblastoma multiforme, which is a grade IV astrocytoma. I thought that Barbara's diagnose was grade III. Also, they are looking for newly diagnosed patients (Barbara does fit into that requirement) that have completed radiation therapy concurrent with chemotherapy using TMZ (temozolomide). The control group will continue with the TMZ alone, while the group that is trying the new device will have the electrical fields together with the TMZ. The patients that are getting the new treatment will have to be seen twice a week for scalp shaving and electrode replacement. They talk about four electrodes, but do not describe the size. It is not clear whether shaving is needed only around the areas of electrode contact - I hope that this is the case.
The center associated with the study in NYC is Weill Cornell Medical College. The PI is Susan Pannullo, MD, and the contact is Euphael Henry, MD, 212-746-2438, euh2002@med.cornell.edu. Phil Gutin is one of the directors for this study, so it seems like a good idea to talk to him about this. The question is: what is the treatment that they plan for Barbara? Were they planning to do radiation together with TMZ chemo? If so, how long will it take? By then, will they still be accepting patients in this clinical trial? They plan to accept 283 patients, of which 2/3 will receive the electrical treatment plus TMZ, and the remaining 1/3 will receive only TMZ. Also, she would need to start treatment at least 4 weeks after but not more than 7 weeks from last dose of temozolomide taken during radiotherapy.
A lot of ifs, but it does seem like a promising treatment, and with little
side effects. Results from the previous clinical trials are promising. I
would say that it is worth asking Gutin about.
