Trial of the Combination of Bevacizumab and Everolimus in Patients With Refractory, Progressive Intracranial Meningioma
Part of paid clinical trials in Orlando, Florida.
- Sponsor
- SCRI Development Innovations, LLC
- Study ID
- NCT00972335
- Phase
- PHASE2
- Status
- Terminated
Conditions
- Intracranial Meningioma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Everolimus — DRUGThis drug will be dosed at 10 mg orally DAILY for the duration of the study.
- Bevacizumab — DRUGThis drug will be given IV at 10 mg/kg on Days 1 and 15 of each 28-day treatment cycle for the duration of the study.
Study Details
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.
Key Dates
- First listed
- Sep 4, 2009
- Start date
- Jan 31, 2010
- Status verified
- Nov 2021
- Primary completion
- Jul 31, 2014
- Completion
- Jul 31, 2014
Study Design
- Enrollment
- 18 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Combination TherapyEverolimus; this drug will be dosed at 10 mg orally DAILY for the duration of the study. Bevacizumab; this drug will be given IV at 10 mg/kg on Days 1 and 15 of each 28-day treatment cycle for the duration of the study
Primary Outcome Measure
Progression-free Survival (PFS), in the Treatment of Patients With Refractory Meningioma. [ Time Frame: 18 months ]
Locations (7)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Florida Hospital Cancer Insitute | Orlando | Florida | 32804 | - |
| Norton Cancer Institute | Louisville | Kentucky | 40207 | - |
| Nebraska Methodist Cancer Center | Omaha | Nebraska | 68114 | - |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | - |
| UT Cancer Insititute Memphis | Memphis | Tennessee | 38104 | - |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37023 | - |
| Peninsula Cancer Institute | Newport News | Virginia | 23601 | - |
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