A Phase II Study of Concurrent Radiation Therapy, Temozolomide, and Bevacizumab Followed by Bevacizumab/Everolimus in the First-line of Treatment of Patients With Glioblastoma Multiforme
Although this maintenance regimen departs from the standard treatment with single agent
temozolomide, we feel this approach may add to the overall efficacy of treatment for the
following reasons: 1) results with bevacizumab/everolimus in renal cell carcinoma suggest
there is at least an additive efficacy when these drugs are used in combination; 2) the
efficacy of single agent temozolomide following standard concurrent radiation
therapy/temozolomide has not been proven, 3) the use of the three-drug maintenance program
(i.e., bevacizumab/everolimus/temozolomide) would probably not be tolerated well on a
chronic basis in this patient population; and 4) the bevacizumab/everolimus combination has
potential advantages as a maintenance therapy, since it has been well tolerated for many
months in patients with other malignancies.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free Survival (PFS)
18 months
No
John D Hainsworth, M.D.
Study Chair
Sarah Cannon Research Institute
United States: Food and Drug Administration
SCRI CNS 10
NCT00805961
January 2009
December 2012
Name | Location |
---|---|
Florida Cancer Specialists | Fort Myers, Florida 33901 |
Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
Research Medical Center | Kansas City, Missouri 64132 |
Consultants in Blood Disorders and Cancer | Louisville, Kentucky 40207 |
South Carolina Oncology Associates, PA | Columbia, South Carolina 29210 |
Virginia Cancer Institute | Richmond, Virginia 23230 |
Methodist Cancer Center | Omaha, Nebraska 68114 |
Peninsula Cancer Institute | Newport News, Virginia 23601 |
Center for Cancer and Blood Disorders | Bethesda, Maryland 20817 |
Clearview Cancer Institute | Huntsville, Alabama 35805 |
Grand Rapids Clinical Oncology Program | Grand Rapids, Michigan 49503 |
St. Louis Cancer Care | Chesterfield, Missouri 63017 |
Tennessee Oncology, PLLC | Clarksville, Tennessee 37043 |