TTFields and Pulsed Bevacizumab for Recurrent Glioblastoma
Status:
Terminated
Trial end date:
2021-06-11
Target enrollment:
Participant gender:
Summary
Glioblastoma multiforme (GBM) is the most common and deadliest primary malignant neoplasm of
the central nervous system in adults. Despite an aggressive multimodality treatment approach
including surgery, radiation therapy and chemotherapy, overall survival remains poor.
Novocure has shown that when properly tuned, very low intensity, intermediate frequency
electric fields (TTFields) stunt the growth of tumor cells. The Optune system (NovoTTFTM
Therapy) is a portable battery operated device, which produces TTFields within the human body
by means of surface transducer arrays. The TTFields are applied to the patient by means of
surface transducer arrays that are electrically insulated, so that resistively coupled
electric currents are not delivered to the patient. Optune is currently FDA-approved as a
single modality treatment for recurrent GBM when both surgical and radiotherapy options have
been exhausted as well as combination with adjuvant temozolomide for newly diagnosed GBM.
This research study is being performed to determine whether or not TTFields combined with
pulsed bevacizumab treatment increases overall survival in patients with
bevacizumab-refractory GBM compared to historical controls treated with continuous
bevacizumab alone or in combination with other chemotherapy.