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 — DRUG
    This drug will be dosed at 10 mg orally DAILY for the duration of the study.
  • Bevacizumab — DRUG
    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.

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 Therapy
    Everolimus; 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)

FacilityCityStateZIPSite coordinators
Florida Hospital Cancer InsituteOrlandoFlorida32804-
Norton Cancer InstituteLouisvilleKentucky40207-
Nebraska Methodist Cancer CenterOmahaNebraska68114-
University of Pittsburgh Medical CenterPittsburghPennsylvania15232-
UT Cancer Insititute MemphisMemphisTennessee38104-
Tennessee Oncology, PLLCNashvilleTennessee37023-
Peninsula Cancer InstituteNewport NewsVirginia23601-

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