This study is designed to determine the objective response rate in patients with relapsed or refractory Hodgkin's disease treated with MDX-060 in combination with gemcitabine or gemcitabine alone.
Secondary objectives include: * to characterize progression-free survival * to characterize time to progression * to determine response duration * to characterize the effect of study drug on health-related quality of life * to explore the correlation of positron emission tomography (PET) scan results with objective responses observed with conventional imaging in this patient population * to characterize the immunogenicity response of MDX-060 * to characterize the safety of MDX-060, and * to characterize the pharmacokinetic profile of MDX-060
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
74
anti-CD30 monoclonal antibody, i.v. weekly x 3 10 mg/kg
City of Hope, National Medical Center
Duarte, California, United States
California Oncology of the Central Valley
Fresno, California, United States
Overall response rate
Time frame: Day 50/57
Progression-free survival
Time frame: Day 50/57
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University of California, San Diego/Moores UCSD Cancer Center
La Jolla, California, United States
H. Lee Moffitt Cancer & Research Institute
Tampa, Florida, United States
Rush Cancer Institute
Chicago, Illinois, United States
St. Francis Hospital Center
Beech Grove, Indiana, United States
American Health Network of Indiana
Indianapolis, Indiana, United States
Division of Hematology/Oncology, Tufts-New England Medical Center
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
...and 7 more locations