ACTR-19. A PHASE 2 STUDY OF TUMOR TREATING FIELDS AND BEVACIZUMAB IN RECURRENT OR PROGRESSIVE MENINGIOMA

ABSTRACT: Abstract Meningioma is the most common primary brain tumor with a prevalence of ~170,000 in the United States. For patients with WHO grade II meningioma, the two- and five-year overall survival was 93% and 73%, respectively. Patients with malignant meningioma (grade III) had significantly worse outcomes, with two-year and five-year overall survival rates of 57% and 42%. The recurrence rate remains high and for grade 3 meningioma overall survival is as low as 3 years after diagnosis. The current treatment for high grade and recurrent meningioma includes maximal safe surgical resection and radiation. Tumor treating fields (TTFields) and Bevacizumab (BEV) have been reported to show activity in recurrent and high-grade meningioma. This Phase 2 Simon two-staged, non-randomized, open-label, phase II, single arm clinical trial [NCT02847559] will investigate the combination of TTFields and BEV in recurrent or progressive meningioma. The primary endpoint is progression free survival (PFS) at 6 months (PFS-6). Secondary endpoints will include overall survival (OS); Tumor Response Rate (TRR), Objective Response Rate (ORR); and Quality of Life (QOL) using FACT-Br questionnaire. Patients (N=27) will receive BEV 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 will receive TTFields 200KHZ daily via the Optune device for over 18 hours. This study is powered to detect a true PFS-6 rate of 20% with 80% probability (80% power) and to detect a true PFS-6 rate of 5% with 90% probability (alpha=0.10). We planned for 27 patients in total to have 24 evaluable patients. For patients who are unable to obtain commercial BEV, the study has been amended to include a monotherapy arm of TTFields alone to increase the pool of eligible patients.

SUBMITTER: Kumthekar P 

PROVIDER: S-EPMC5692851 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature