Galiximab in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma
- Conditions
- Lymphoma
- Interventions
- Biological: galiximab
- Registration Number
- NCT00516217
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Monoclonal antibodies, such as galiximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them.
PURPOSE: This phase II trial is studying how well galiximab works in treating patients with relapsed or refractory Hodgkin's lymphoma.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Galaximab galiximab Induction: 500 mg/m\^2 by IV over 60 minutes days 1, 8, 15 \& 22 Extended Induction: 500 mg/m\^2 by IV every 4 weeks until disease progression or unacceptable toxicity
- Primary Outcome Measures
Name Time Method Overall Response Duration of treatment (up to 10 years) Overall response is defined as achievement of a complete response (CR) or partial response (PR) as defined by the Revised Response Criteria for Malignant Lymphoma.
CR: complete disappearance of all detectable disease PR: \>=50% decrease in the sum of the product of diameters of indicator lesions.
- Secondary Outcome Measures
Name Time Method 12 Month Overall Survival Rate 12 months Percentage of patients who were alive at 12 months. The 12-month survival rate was estimated using the Kaplan Meier method.
6 Month Progression Free Survival Rate 6 months Percentage of patients who were progression free at 6 months. The 6-month progression free rate was estimated using the Kaplan Meier method.
Relapse was assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Progression required a appearance of any new lesion \> 1.5 cm, at least 50% increase from nadir in the sum of products of involved nodes, or a 50% increase in the longest diameter of any single node.
Trial Locations
- Locations (56)
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Galesburg Clinic, PC
🇺🇸Galesburg, Illinois, United States
Perry Memorial Hospital
🇺🇸Princeton, Illinois, United States
Elkhart General Hospital
🇺🇸Elkhart, Indiana, United States
South Bend Clinic
🇺🇸South Bend, Indiana, United States
CancerCare of Maine at Eastern Maine Medical Center
🇺🇸Bangor, Maine, United States
Cancer Resource Center - Lincoln
🇺🇸Lincoln, Nebraska, United States
Kinston Medical Specialists
🇺🇸Kinston, North Carolina, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Eureka Community Hospital
🇺🇸Eureka, Illinois, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Hopedale Medical Complex
🇺🇸Hopedale, Illinois, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
St. Joseph Medical Center
🇺🇸Bloomington, Illinois, United States
Memorial Hospital
🇺🇸Carthage, Illinois, United States
Mason District Hospital
🇺🇸Havana, Illinois, United States
McDonough District Hospital
🇺🇸Macomb, Illinois, United States
BroMenn Regional Medical Center
🇺🇸Normal, Illinois, United States
Community Hospital of Ottawa
🇺🇸Ottawa, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
🇺🇸Ottawa, Illinois, United States
Cancer Treatment Center at Pekin Hospital
🇺🇸Pekin, Illinois, United States
Proctor Hospital
🇺🇸Peoria, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
🇺🇸Peoria, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
OSF St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
Illinois Valley Community Hospital
🇺🇸Peru, Illinois, United States
St. Margaret's Hospital
🇺🇸Spring Valley, Illinois, United States
Howard Community Hospital
🇺🇸Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
🇺🇸La Porte, Indiana, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
Saint Joseph Regional Medical Center
🇺🇸South Bend, Indiana, United States
Union Hospital Cancer Program at Union Hospital
🇺🇸Elkton MD, Maryland, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
🇺🇸Saint Louis, Missouri, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
Immanuel Medical Center
🇺🇸Omaha, Nebraska, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center
🇺🇸Omaha, Nebraska, United States
Creighton University Medical Center
🇺🇸Omaha, Nebraska, United States
Cancer Institute of New Jersey at Cooper - Voorhees
🇺🇸Voorhees, New Jersey, United States
New York Weill Cornell Cancer Center at Cornell University
🇺🇸New York, New York, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Randolph Hospital
🇺🇸Asheboro, North Carolina, United States
Presbyterian Cancer Center at Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
🇺🇸Greensboro, North Carolina, United States
Annie Penn Cancer Center
🇺🇸Reidsville, North Carolina, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
Danville Regional Medical Center
🇺🇸Danville, Virginia, United States
Virginia Commonwealth University Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Tunnell Cancer Center at Beebe Medical Center
🇺🇸Lewes, Delaware, United States
Lakeland Regional Cancer Care Center - St. Joseph
🇺🇸St. Joseph, Michigan, United States
Graham Hospital
🇺🇸Canton, Illinois, United States
Community Cancer Center
🇺🇸Normal, Illinois, United States
Galesburg Cottage Hospital
🇺🇸Galesburg, Illinois, United States