NCT01894061

NovoTTF-100A With Bevacizumab (Avastin) in Patients With Recurrent Glioblastoma

A Prospective Phase II Trial of NovoTTF-100A With Bevacizumab (Avastin) in Patients With Recurrent Glioblastoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

NovoTTF-100A is a device and Bevacizumab is a study drug that have both been approved by the FDA (Food and Drug Administration) for use as monotherapy in treating glioblastoma multiforme. The NovoTTF-l00A is a portable battery operated device which produces TTFields within the human body using surface electrodes (transducer arrays). Intermediate frequency electric fields (TTFields) stunt the growth of tumor cells. The purpose of this study is to determine the efficacy of the combination of Bevacizumab and NovoTTF-100A in Bevacizumab naive (meaning have never received bevacizumab before) patients with recurrent glioblastoma (GBM) as measured by 6-month progression free survival.

Detailed description

This will be an open label Phase II trial in adults with recurrent glioblastoma (GBM). The NovoTTF-100A treatment and Bevacizumab will be administered on an outpatient basis; NovoTTF-100A treatment will be initiated in the outpatient clinic. PRIMARY OBJECTIVES: I. To determine the efficacy of the combination of bevacizumab and NovoTTF-100A in bevacizumab-naive patients with recurrent glioblastoma (GBM) as measured by 6-month progression-free survival (PFS6). SECONDARY OBJECTIVES: I. To assess safety and tolerability of the combination of bevacizumab and Novo-TTF-100A in this patient population. II. To evaluate overall survival in this population. III. To determine objective response rate (ORR) by modified Revised Assessment in Neuro-Oncology (RANO) criteria in this population. IV. To assess time-to-progression in this population. V. To assess neurocognitive function (NCF) and quality of life (QOL) in this population. OUTLINE: Patients receive bevacizumab intravenously (IV) on days 1 and 15. Patients also undergo electric field therapy with NovoTTF-100A for at least 18 hours daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for at least 28 days.

Conditions

• Adult Giant Cell Glioblastoma
• Adult Glioblastoma
• Adult Gliosarcoma
• Recurrent Adult Brain Tumor

Interventions

Type	Name	Description
BIOLOGICAL	Bevacizumab	Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle. The dose of bevacizumab will be 10 mg/kg of actual body weight.
DEVICE	NovoTTF-l00A	NovoTTF-100A will be worn continuously.
OTHER	Quality of Life Assessment	Functional Assessment of Cancer Therapy including Brain Tumor module (FACT-Br) questionnaire

Timeline

• Start date: 2013-09-18
• Primary completion: 2019-07-01
• Completion: 2019-07-01
• First posted: 2013-07-09
• Last updated: 2025-02-17
• Results posted: 2025-02-17

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study