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

Study Overview
=================
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

Official Title
-----------------
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

Conditions
-----------------
Hodgkin's Disease

Intervention / Treatment
-----------------
* Drug: MDX-060


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MDX-060 plus standard of care<br>MDX-060 in combination with gemcitabine | Drug: MDX-060<br>* anti-CD30 monoclonal antibody, i.v. weekly x 3 10 mg/kg<br>* Other names: anti-CD30;|
| Active Comparator: Standard of care<br>Gemcitabine | Drug: MDX-060<br>* anti-CD30 monoclonal antibody, i.v. weekly x 3 10 mg/kg<br>* Other names: anti-CD30;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  | Day 50/57 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | Day 50/57 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
relapsed or refractory Hodgkin's Disease