NCT02743078

Optune® Plus Bevacizumab in Bevacizumab-Refractory Recurrent Glioblastoma

Phase II Trial Of Optune® Plus Bevacizumab In Bevacizumab-Refractory Recurrent Glioblastoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: RTOG Foundation, Inc. · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial will investigate the efficacy and safety of the addition of Optune (Tumor Treating Fields \[TTFields\] Therapy) to bevacizumab for patients with bevacizumab-refractory recurrent glioblastoma.

Detailed description

Patients that have recurrent glioblastoma that has progressed on bevacizumab continue to receive bevacizumab with the addition of Tumor Treating Fields Therapy. Treatment is given until disease progression or the development of adverse events that require complete discontinuation.

Conditions

• Glioblastoma
• Glioma
• Gliosarcoma

Interventions

Type	Name	Description
DRUG	Bevacizumab	10 mg/kg every 2 weeks intravenously over 30 minutes.
DEVICE	TTFields Therapy	Device is worn continuously at least 18 hours a day on average, with 1-3 days off every four weeks.

Timeline

• Start date: 2017-05-09
• Primary completion: 2019-10-15
• Completion: 2019-10-15
• First posted: 2016-04-19
• Last updated: 2021-06-02
• Results posted: 2020-11-17

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study