A Phase II Study of MDX-060 in Subjects With Relapsed or Refractory Hodgkin's Disease
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
1 other identifier
interventional
74
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2005
Typical duration for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 30, 2006
CompletedFirst Posted
Study publicly available on registry
February 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedOctober 12, 2015
September 1, 2015
2.5 years
January 30, 2006
September 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall response rate
Day 50/57
Secondary Outcomes (1)
Progression-free survival
Day 50/57
Study Arms (2)
MDX-060 plus standard of care
EXPERIMENTALMDX-060 in combination with gemcitabine
Standard of care
ACTIVE COMPARATORGemcitabine
Interventions
anti-CD30 monoclonal antibody, i.v. weekly x 3 10 mg/kg
Eligibility Criteria
You may qualify if:
- Diagnosis of Hodgkin's disease \[HD\] (excluding HIV-associated HD)
- 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.
You may not qualify if:
- Previous treatment with any anti-CD30 antibody
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
City of Hope, National Medical Center
Duarte, California, 91010, United States
California Oncology of the Central Valley
Fresno, California, 93710, United States
University of California, San Diego/Moores UCSD Cancer Center
La Jolla, California, 92093-0698, United States
H. Lee Moffitt Cancer & Research Institute
Tampa, Florida, 33612, United States
Rush Cancer Institute
Chicago, Illinois, 60612, United States
St. Francis Hospital Center
Beech Grove, Indiana, 46107, United States
American Health Network of Indiana
Indianapolis, Indiana, 46237, United States
Division of Hematology/Oncology, Tufts-New England Medical Center
Boston, Massachusetts, 02111, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Nevada Cancer Institute
Las Vegas, Nevada, 89135, United States
The Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
Roswell Park Cancer Center
Buffalo, New York, 14263, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Carolina BioOncology Institute, PLLC
Huntersville, North Carolina, 28078, United States
M.D. Anderson Cancer Center, The University of Texas
Houston, Texas, 77030, United States
Mary Babb Randolph Cancer Center
Morgantown, West Virginia, 26506-9162, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medarex Medical Monitor
Medarex
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2006
First Posted
February 1, 2006
Study Start
November 1, 2005
Primary Completion
May 1, 2008
Study Completion
October 1, 2009
Last Updated
October 12, 2015
Record last verified: 2015-09