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 ]

Progression-free survival (PFS) is defined as the time from randomization until objective tumor progression (PD) or death. Progression is defined per MacDonald criteria for response as ≥25% increase in size of enhancing tumor or any new tumor on MRI scan, neurologically worse, and steroids stable or increased.


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