A Phase II Study of Galiximab (Anti-CD80) for Patients With Relapsed/Refractory Hodgkin Lymphoma
OBJECTIVES:
Primary
- To determine the response rate (complete and overall response) in patients with
relapsed or refractory Hodgkin lymphoma (HL) treated with galiximab.
Secondary
- To assess the duration of response, progression-free survival, and overall survival of
patients with relapsed or refractory HL.
- To assess the safety and tolerability of galiximab in patients with relapsed or
refractory HL.
- To determine if FDG-PET correlates with outcome in patients with relapsed or refractory
HL treated with galiximab.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive galiximab IV over 60 minutes on days 1, 8, 15, and
22 in month 1.
- Extended induction therapy: Patients receive galiximab IV over 60 minutes once every
four weeks in the absence of disease progression or unacceptable toxicity.
Patients also undergo FDG-PET/CT imaging at baseline and at time of first restaging (within
7 days prior to week 8 treatment).
After completion of study treatment, patients are followed periodically for 10 years.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response
2 years
No
Sonali M. Smith, MD
Study Chair
University of Chicago
United States: Food and Drug Administration
CDR0000561185
NCT00516217
June 2008
December 2018
Name | Location |
---|---|
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
Mount Sinai Medical Center | New York, New York 10029 |
Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
New York Weill Cornell Cancer Center at Cornell University | New York, New York 10021 |
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington, District of Columbia 20007 |
CancerCare of Maine at Eastern Maine Medical Center | Bangor, Maine 04401 |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
Virginia Commonwealth University Massey Cancer Center | Richmond, Virginia 23298-0037 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Howard Community Hospital | Kokomo, Indiana 46904 |
South Bend Clinic | South Bend, Indiana 46617 |
Lakeland Regional Cancer Care Center - St. Joseph | St. Joseph, Michigan 49085 |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus, Ohio 43210-1240 |
St. Joseph Medical Center | Bloomington, Illinois 61701 |
Graham Hospital | Canton, Illinois 61520 |
Memorial Hospital | Carthage, Illinois 62321 |
Eureka Community Hospital | Eureka, Illinois 61530 |
Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
Mason District Hospital | Havana, Illinois 62644 |
Hopedale Medical Complex | Hopedale, Illinois 61747 |
McDonough District Hospital | Macomb, Illinois 61455 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Community Cancer Center | Normal, Illinois 61761 |
Community Hospital of Ottawa | Ottawa, Illinois 61350 |
Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa, Illinois 61350 |
Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria, Illinois 61615 |
OSF St. Francis Medical Center | Peoria, Illinois 61637 |
Proctor Hospital | Peoria, Illinois 61614 |
Illinois Valley Community Hospital | Peru, Illinois 61354 |
Perry Memorial Hospital | Princeton, Illinois 61356 |
St. Margaret's Hospital | Spring Valley, Illinois 61362 |
Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
Immanuel Medical Center | Omaha, Nebraska 68122 |
Creighton University Medical Center | Omaha, Nebraska 68131-2197 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
Danville Regional Medical Center | Danville, Virginia 24541 |
Cancer Resource Center - Lincoln | Lincoln, Nebraska 68510 |
Randolph Hospital | Asheboro, North Carolina 27203 |
Moses Cone Regional Cancer Center at Wesley Long Community Hospital | Greensboro, North Carolina 27401 |
Annie Penn Cancer Center | Reidsville, North Carolina 27320 |
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224-1791 |
Tunnell Cancer Center at Beebe Medical Center | Lewes, Delaware 19958 |
Union Hospital Cancer Program at Union Hospital | Elkton MD, Maryland 21921 |
Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha, Nebraska 68124 |
Kinston Medical Specialists | Kinston, North Carolina 28501 |
Galesburg Clinic, PC | Galesburg, Illinois 61401 |