(PULSED AVASTIN) A Phase 2, Multi-center, Single Arm, Histologically Controlled Study Testing the Combination of TTFields and Pulsed Bevacizumab Treatment in Patients With Bevacizumab-refractory Recurrent Glioblastoma

Purpose

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.

Eligibility 

  • 22 years and older
  • Disease: Brain tumor
  • Disease type: Recurrent Glioblastoma Multiforme (GBM)

For additional information about eligibility criteria, please contact the study coordinator Deborah Sampson:

Age

18 to 65
65 and over

Gender

Male
Female

Can be done from home

No

Keywords

Recurrent Glioblastoma, Glioblastoma multiforme

Principal Investigator

David D Tran, M.D.

Department

MD-NEUROLOGICAL SURGERY

Contact Information

deborah.sampson@neurosurgery.ufl.edu

(352) 273-9000

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