Finding studies
Finding studies
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Lead
Northwestern University
With
PRIMARY OBJECTIVES: I. TTo determine the efficacy of Optune (TTF) therapy with Bevacizumab as assessed by Progression Free Survival (PFS) at 6 months (PFS-6) in patients with recurrent or progressive meningioma. PFS-6 will be defined from the time of registration to the time of confirmed progression. In cases where this might be unclear, patients may continue on trial and if progression is confirmed later, then the original date where first changes occurred will be used. SECONDARY OBJECTIVES: I. To collect the safety and tolerability data of Optune (TTF) therapy in combination with bevacizumab. II. To determine overall survival (OS). III. To determine tumor response rate (TRR). IV. To determine Objective Response Rate (ORR) V. To assess quality of life with treatment (QOL) using FACT-Br questionnaire. OUTLINE: This is a trial of Optune with concurrent standard of care treatment bevacizumab. Both treatments can start simultaneously with either starting first, but both must start within a window of 1 week. Patients receive bevacizumab intravenously (IV) over 30-90 minutes on days 1 and 15 of courses 1-4. Beginning on day 1 of course 5, patients may choose to receive bevacizumab IV every 3 weeks or remain on the every 2-week schedule. Patients also undergo electric field therapy using Optune (formerly NovoTTF-200A System) daily for at least18 hours. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who are responding will remain on study treatment for 6 months.After 6 months, patients may still continue on OPTUNE and Bevacizumab at the discretion of their treating physician. NOTE:At any point, if patients discontinue bevacizumab secondary to side effects, then they may continue Optune alone per treating physician's discretion. After completion of study treatment, patients are followed up every 3 months for 2 years.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
