Brain Tumor Activism: NovoTTF-100A

This petition is now closed!

Novocure NovoTTF-100A device is up for FDA approval!

We need you to submit your thoughts on the approval, and help us get a lot of responses!

Al Musella, DPM, President of the Musella Foundation, will be one of the patient representatives giving input to the FDA committee, and needs your permission to speak for you - as well as your thoughts to present as a petition. The more people we can get involved, the more effective our presentation will be.

About the NovoTTF-100A: this is an external device - electrodes are applied to the scalp and plugged into a control panel. (You can cover it with a wig or hat!) The device emits an electromagnetic field that interferes with the ability of the cancer cells to divide. I know it sounds like science fiction, but it has been shown to work on cell cultures, mice and people with cancer. If you already know about the device, skip to the questions way below. Otherwise, please take the time to look through the following articles. We will accept negative comments, but only if you have read these articles first.

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Device for Glioblastoma May Offer Advantage Over Chemo from Internal Medicine News - gives nice non technical overview

Disruption of Cancer Cell Replication by Alternating Electric Fields. Full article from 2004 Cancer Research – pre-clinical research - pretty technical but explains how it works on mice and in the lab.

Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Full article from the Proceedings of the National Academy Of Sciences: talks about the first human GBM trial of the device. They tried the device on 10 patients with recurrent gbms. They reported a median overall survival of 62 weeks, with 3 of the patients alive at the end of the trial. This is about double that expected of historical controls. A recent (Jan 2011) follow up communication with the author reveals that 2 of these patients are still alive now, over 6 years since starting the trial.

Chemotherapeutic treatment efficacy and sensitivity are increased by adjuvant alternating electric fields (TTFields). Full journal article from BMC Medical Physics Shows how the Novo TTF device enhances the effectiveness of chemotherapy in the lab, and also discusses 2 human trials: 10 newly diagnosed and 10 recurrent glioblastoma multiforme. (The recurrent group is the same trial mentioned above). For the newly diagnosed group, they used the device in combination with the standard treatments and the progression free survival and overall survival reported was over 300% longer than expected from historical controls. Follow up communication with the authors in January 2011 reveal that 5 of the 10 newly diagnosed glioblastoma patients are still alive today - over 6 years from when they started the trial.

A prospective, randomized, open-label, phase III clinical trial of NovoTTF-100A versus best standard of care chemotherapy in patients with recurrent glioblastoma. An abstract presented at the 2010 ASCO (American Society of Clinical Oncology) meeting discusses a trial in which the device alone was tested against the best of whatever treatments were available. Many in the control group used Avastin, vaccines, other clinical trials, targeted drugs, and alternate schedules of temodar or other therapies. The result was that overall, there was a small improvement in progression free survival and overall survival with the Novo TTF device, but there were no significant side effects whereas there were many in the control group. My impression is that this means the device has an effect, and it is at least as good as anything else available, with no side effects.

Subgroup and quality of life analyses of the phase III clinical trial ofNovoTTF-100A versus best standard chemotherapy for recurrent glioblastoma. An abstract presented at the 2010 SNO (Society of Neuro-oncology) annual meeting - discusses subgroup analysis of the recurrent gbm trial mentioned above. Basically if you take the people who were in relatively good shape and under 60 years old, the Novo TTF device did much better the control group (which was the best of available treatments): 1-year survival was 35% vs. 20% and PFS6 was 25.6% vs. 7.7%. The way I interpret this is that some of the older patients in the trial were unable to correctly utilize the device or it was too late for anything to help. Patients who were able to use it correctly did well with it.

Please fill out the form below - it will take you to the next page where we will have a customized letter based on what you entered. You can then either submit the letter or edit it to add your personal comments! All fields are required. We will not add you to our regular mailing list - we will only use your email one time in the future for the next letter writing campaign - but never for a fundraiser. Note that this will be submitted to the FDA, and the FDA MIGHT post it on their website - so do not submit it if you do not wish this information to be public. Note that for this meeting, only letters from the USA can be used. We will accept letters from outside the USA - and keep them on file for when needed to help approval in that country!