A Prospective, Multi-center Trial of NovoTTF-100A Together With Temozolomide Compared to Temozolomide Alone in Patients with Newly Diagnosed GBM
ID Number 12-1613Principal Investigator(s)
Isabelle M. Germano
Department(s) or Division(s)
The purpose of this study is to evaluate the safety and effectiveness of an experimental device called NovoTTF-100A. NovoTTF-100A is an experimental device that has not been approved by the FDA for use in treating newly diagnosed Glioblastoma multiforme. Though no direct benefit can be guaranteed to you by joining this trial, your participation in the study will help us to test whether NovoTTF-100A treatment together with Temozolomide is superior to Temozolomide treatment alone in newly diagnosed Glioblastoma multiforme.
You may qualify to take part in this research study because you have been newly diagnosed with Glioblastoma multiforme (brain tumor). This study involves collecting data on the clinical results of an experimental device, the NovoTTF-100A, for the treatment of your brain tumor. Glioblastoma multiforme (GMB) is a type of brain tumor that is characterized by recurrent and progressive neurological and functional deterioration. Since standard treatment (Surgery followed by Radiation therapy with Temozolomide and then continuing on Temozolomide alone) in patients diagnosed with GBM is not very efficient, your doctor has recommended participating in a research study to compare treatment using a new experimental device, the NovoTTF-100A together with maintenance Temozolomide, to maintenance Temozolomide alone (following surgery and radiation therapy with concomitant Temozolomide).
NovoTTF-100A is an experimental device that has not been approved by the FDA for use in treating newly diagnosed Glioblastoma multiforme. Thus, there may be no direct benefit to you from participating in this study. The effect of the electric fields generated by the device (TTFields) has been tested in two pilot trials in humans and in a pivotal trial for patients with recurrent GBM.
Recruiting Patients: Yes