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

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.

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