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Brief Title: Bevacizumab With or Without Radiation Therapy in Treating Patients With Recurrent Glioblastoma
Official Title: Randomized Phase II Trial of Concurrent Bevacizumab and Re-Irradiation Versus Bevacizumab Alone as Treatment for Recurrent Glioblastoma
Study ID: NCT01730950
Brief Summary: This randomized phase II trial studies how well bevacizumab with or without radiation therapy works in treating patients with recurrent glioblastoma. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet know whether bevacizumab is more effective with or without radiation therapy in treating patients with recurrent glioblastoma
Detailed Description: PRIMARY OBJECTIVES: I. To establish an improvement in overall survival in recurrent glioblastoma (GBM) patients receiving bevacizumab and re-irradiation compared with patients receiving bevacizumab alone. SECONDARY OBJECTIVES: I. To estimate and compare the rate of objective response in patients with measurable disease. II. To estimate and compare the 6-month progression-free survival rate. III. To estimate and compare progression-free survival. IV. To estimate and compare the rate of treatment adverse events. V. To estimate and compare the rate of grade 3+ acute or delayed central nervous system (CNS) toxicity. OUTLINE: Patients are randomized to 1 of 2 treatment arms. In both arms, courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 2 months for 1 year, every 6 months for 1 year and then annually thereafter.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham, Birmingham, Alabama, United States
Arizona Oncology Services Foundation, Phoenix, Arizona, United States
Arizona Oncology-Deer Valley Center, Phoenix, Arizona, United States
John Muir Medical Center, Walnut Creek, California, United States
Yale University, New Haven, Connecticut, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, United States
Queen's Medical Center, Honolulu, Hawaii, United States
Radiation Oncology Associates PC, Fort Wayne, Indiana, United States
IU Health Methodist Hospital, Indianapolis, Indiana, United States
Memorial Hospital of South Bend, South Bend, Indiana, United States
Norton Health Care Pavilion - Downtown, Louisville, Kentucky, United States
Maine Medical Center- Scarborough Campus, Scarborough, Maine, United States
Lowell General Hospital, Lowell, Massachusetts, United States
University of Michigan University Hospital, Ann Arbor, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
University of Rochester, Rochester, New York, United States
Cone Health Cancer Center, Greensboro, North Carolina, United States
Summa Akron City Hospital, Akron, Ohio, United States
Summa Barberton Hospital, Barberton, Ohio, United States
Lancaster General Hospital, Lancaster, Pennsylvania, United States
Radiation Therapy Oncology Group, Philadelphia, Pennsylvania, United States
Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
University of Texas Medical Branch, Galveston, Texas, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital, Yakima, Washington, United States
Saint Vincent Hospital, Green Bay, Wisconsin, United States
Saint Mary's Hospital, Green Bay, Wisconsin, United States
Bay Area Medical Center, Marinette, Wisconsin, United States
Door County Cancer Center, Sturgeon Bay, Wisconsin, United States
Name: Christina Tsien
Affiliation: Washington University School of Medicine
Role: PRINCIPAL_INVESTIGATOR
Name: Jeffrey Raizer, MD
Affiliation: Northwestern University
Role: STUDY_CHAIR
Name: Adam P. Dicker, MD, PhD
Affiliation: Jefferson Medical College of Thomas Jefferson University
Role: STUDY_CHAIR
Name: Martha M. Matuszak, PhD
Affiliation: University of Michigan
Role: STUDY_CHAIR