TTFields and Pulsed Bevacizumab for Recurrent Glioblastoma

• Status: Terminated
• Trial end date: 2021-06-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Collaborator: NovoCure Ltd.
• Treatments: Bevacizumab

Criteria

Inclusion Criteria:

• Histologically confirmed GBM, WHO grade IV. GBM variants and secondary GBM are allowed in any recurrence (including multiple) and have been treated with radiation and chemotherapy.

• Unequivocal evidence of tumor progression during prior bevacizumab treatment per RANO criteria.

• Patient is a candidate for, and agrees to proceed with additional bevacizumab treatment.

• Male or female at least 22 years of age or older.

• Karnofsky Performance Scale (KPS) ≥ 60%.

• Planned treatment with TTFields therapy.

• Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days of treatment.

• Participants of childbearing/reproductive potential must use effective contraception.

• Participants must be able to understand and willing to comply with protocol requirements as assessed by the investigator.

• Signed informed consent according to institutional guidelines prior to registration.

Exclusion Criteria:

• Inability to undergo brain MRI due to medical or personal reasons.

• Currently receiving investigational agents that are intended as treatments of recurrent GBM.

• Skull defect such as missing bone or bullet fragments.

• Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, heart attack within the previous 12 months, stroke (except for TIA) within the previous 6 months, or psychiatric illness/social situations that would limit compliance with study requirements.

• Intracranial hemorrhage except for tumor associated micro hemorrhage.

• Women who are pregnant or breastfeeding.

• Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, vagus nerve stimulator, and other implanted electronic devices in the brain or the spinal cord.

• Tumor located entirely in the infratentorium.

• History of hypersensitivity to hydrogel.