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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00284804
First received: January 30, 2006
Last updated: November 27, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Hodgkin's Disease
Drug: MDX-060
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: Day 50/57 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Day 50/57 ] [ Designated as safety issue: No ]

Enrollment: 74
Study Start Date: November 2005
Study Completion Date: October 2009
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MDX-060 plus standard of care
MDX-060 in combination with gemcitabine
Drug: MDX-060
anti-CD30 monoclonal antibody, i.v. weekly x 3 10 mg/kg
Other Name: anti-CD30
Active Comparator: Standard of care
Gemcitabine
Drug: MDX-060
anti-CD30 monoclonal antibody, i.v. weekly x 3 10 mg/kg
Other Name: anti-CD30

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00284804

Locations
United States, California
City of Hope, National Medical Center
Duarte, California, United States, 91010
California Oncology of the Central Valley
Fresno, California, United States, 93710
University of California, San Diego/Moores UCSD Cancer Center
LaJolla, California, United States, 92093-0698
United States, Florida
H. Lee Moffitt Cancer & Research Institute
Tampa, Florida, United States, 33612
United States, Illinois
Rush Cancer Institute
Chicago, Illinois, United States, 60612
United States, Indiana
St. Francis Hospital Center
Beech Grove, Indiana, United States, 46107
American Health Network of Indiana
Indianapolis, Indiana, United States, 46237
United States, Massachusetts
Division of Hematology/Oncology, Tufts-New England Medical Center
Boston, Massachusetts, United States, 02111
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
United States, New Jersey
The Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
United States, New York
Roswell Park Cancer Center
Buffalo, New York, United States, 14263
Mount Sinai School of Medicine
New York, New York, United States, 10029
United States, North Carolina
Carolina BioOncology Institute, PLLC
Huntersville, North Carolina, United States, 28078
United States, Texas
M.D. Anderson Cancer Center, The University of Texas
Houston, Texas, United States, 77030
United States, West Virginia
Mary Babb Randolph Cancer Center
Morgantown, West Virginia, United States, 26506-9162
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Medarex Medical Monitor Medarex
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00284804     History of Changes
Other Study ID Numbers: MDX060-05/05E
Study First Received: January 30, 2006
Last Updated: November 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
relapsed or refractory Hodgkin's Disease

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 23, 2014