Adult Glioblastoma Clinical Trial
Official title:
A Prospective Phase II Trial of NovoTTF-100A With Bevacizumab (Avastin) in Patients With Recurrent Glioblastoma
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.
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.
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