Spots Global Cancer Trial Database for A Phase II Study of MDX-060 in Subjects With Relapsed or Refractory Hodgkin's Disease
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Trial Identification
Brief Title: A Phase II Study of MDX-060 in Subjects With Relapsed or Refractory Hodgkin's Disease
Official Title: An Open-label, Randomized, Multicenter, Phase II Study of MDX-060 in Combination With Gemcitabine, MDX060 in Combination With Dexamethasone, and Gemcitabine Monotherapy in Patients With Relapsed or Refractory Hodgkin's Disease
Study ID: NCT00284804
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope, National Medical Center, Duarte, California, United States
California Oncology of the Central Valley, Fresno, California, United States
University of California, San Diego/Moores UCSD Cancer Center, LaJolla, 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
Nevada Cancer Institute, Las Vegas, Nevada, United States
The Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Roswell Park Cancer Center, Buffalo, New York, United States
Mount Sinai School of Medicine, New York, New York, United States
Carolina BioOncology Institute, PLLC, Huntersville, North Carolina, United States
M.D. Anderson Cancer Center, The University of Texas, Houston, Texas, United States
Mary Babb Randolph Cancer Center, Morgantown, West Virginia, United States
Contact Details
Name: Medarex Medical Monitor
Affiliation: Medarex
Role: STUDY_DIRECTOR
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