A Phase II Study of MDX-060 in Subjects With Relapsed or Refractory Hodgkin's Disease
Hodgkin's Disease
About this trial
This is an interventional treatment trial for Hodgkin's Disease focused on measuring relapsed or refractory Hodgkin's Disease
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Sites / Locations
- City of Hope, National Medical Center
- California Oncology of the Central Valley
- University of California, San Diego/Moores UCSD Cancer Center
- H. Lee Moffitt Cancer & Research Institute
- Rush Cancer Institute
- St. Francis Hospital Center
- American Health Network of Indiana
- Division of Hematology/Oncology, Tufts-New England Medical Center
- Henry Ford Health System
- Mayo Clinic
- Nevada Cancer Institute
- The Cancer Institute of New Jersey
- Roswell Park Cancer Center
- Mount Sinai School of Medicine
- Carolina BioOncology Institute, PLLC
- M.D. Anderson Cancer Center, The University of Texas
- Mary Babb Randolph Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
MDX-060 plus standard of care
Standard of care
MDX-060 in combination with gemcitabine
Gemcitabine