A Phase II Study of MDX-060 in Subjects With Relapsed or Refractory Hodgkin's Disease
NCT ID: NCT00284804
Last Updated: 2015-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
74 participants
INTERVENTIONAL
2005-11-30
2009-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
MDX-060 in Patients With Relapsed or Refractory Classic Systemic or Primary Cutaneous Anaplastic Large Cell Lymphoma
NCT00298467
Phase 1 Study of MDX-1401 in Patients With CD30-positive Refractory/Relapsed Hodgkin's Lymphoma
NCT00634452
Combination Chemotherapy in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma
NCT00006029
Mocetinostat (MGCD0103) Plus Brentuximab Vedotin (SGN-35) in Patients With Relapsed or Refractory Hodgkin Lymphoma
NCT02429375
Study of Motexafin Gadolinium for the Treatment of Non-Hodgkin's Lymphoma
NCT00086034
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MDX-060 plus standard of care
MDX-060 in combination with gemcitabine
MDX-060
anti-CD30 monoclonal antibody, i.v. weekly x 3 10 mg/kg
Standard of care
Gemcitabine
MDX-060
anti-CD30 monoclonal antibody, i.v. weekly x 3 10 mg/kg
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MDX-060
anti-CD30 monoclonal antibody, i.v. weekly x 3 10 mg/kg
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients must have read, understood, and provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained
* Patients must have failed or relapsed following second line (i.e., salvage) chemotherapy or relapsed or failed following autologous stem cell transplant
* ECOG Performance Status of 0-2
* Patients must have bi-measurable disease
* At least 4 weeks since the last chemotherapy or radiation therapy with clinical evidence of recovery from any toxicity associated with such treatment
* Life expectancy 12 weeks or greater
* Screening laboratory values must be met
* Patients on corticosteroids must be tapered off the medication 2 weeks prior to study drug administration and remain off corticosteroids until study completion.
Exclusion Criteria
* History of allogeneic transplant
* Any tumor lesion 10cm or greater in diameter
* Any other malignancy, excluding basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ. Any cancer from which the patient has been disease free for at least 5 years is permissible.
* Any significant active or chronic infection
* Apparent active or latent tuberculosis (TB) infection
* Patients who are pregnant or nursing
* Any underlying medical condition which, in the investigator's opinion, will make the administration of the study drug hazardous or obscure the interpretation of adverse events
* Concomitant chemotherapy, steroids, investigational agents, other anti-HD biologics, or radiation therapy
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medarex Medical Monitor
Role: STUDY_DIRECTOR
Medarex
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
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
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MDX060-05/05E
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.