Clinical Trial: Trial of the Combination of Bevacizumab and Everolimus in Patients With Refractory, Progressive Intracranial Meningioma
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Phase II Trial of the Combination of Bevacizumab and Everolimus in Patients With Refractory, Progressive Intracranial Meningioma
Brief Summary: In this multicenter, Phase II trial, the investigators plan to evaluate the activity of the combination of bevacizumab and everolimus in patients with recurrent, progressive meningioma following maximal treatment with surgical resection and local radiation therapy. Although these patients are relatively rare, there is currently no established standard of treatment for a disease that causes a great deal of morbidity, and that is eventually fatal.
Detailed Summary:
Sponsor: SCRI Development Innovations, LLC
Current Primary Outcome: Progression-free Survival (PFS), in the Treatment of Patients With Refractory Meningioma. [ Time Frame: 18 months ]
Original Primary Outcome: To evaluate the efficacy of the combination of bevacizumab and everolimus, by measurement of progression-free survival (PFS), in the treatment of patients with refractory meningioma. [ Time Frame: 18 months ]
Current Secondary Outcome:
- To Evaluate the Toxicity of Bevacizumab/Everolimus in Patients With Recurrent Meningioma. [ Time Frame: 18 months ]
- To Correlate the Activity of This Treatment Regimen With Expression of Selected Intra-tumoral Biomarkers. [ Time Frame: 18 months ]
Original Secondary Outcome: Same as current
Information By: SCRI Development Innovations, LLC
Dates:
Date Received: September 2, 2009
Date Started: January 2010
Date Completion:
Last Updated: May 18, 2015
Last Verified: May 2015