A Phase II Study of MDX-060 in Subjects With Relapsed or Refractory Hodgkin's Disease

Completed · Phase 2

Conditions studied: Hodgkin's Disease

In brief

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.

Key facts

Study ID

NCT00284804

Run by

Bristol-Myers Squibb

People needed

74

Starts

2005-11-01

Expected to finish

2009-10-01

Last updated by the study team

2015-10-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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