A Phase II Study of MDX-060 in Subjects With Relapsed or Refractory Hodgkin's Disease
- Registration Number
- NCT00284804
- Lead Sponsor
- Bristol-Myers Squibb
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 74
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MDX-060 plus standard of care MDX-060 MDX-060 in combination with gemcitabine Standard of care MDX-060 Gemcitabine
- Primary Outcome Measures
Name Time Method Overall response rate Day 50/57
- Secondary Outcome Measures
Name Time Method Progression-free survival Day 50/57
Related Research Topics
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Trial Locations
- Locations (17)
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
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