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

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

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