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

September 23, 2015 updated by: Bristol-Myers Squibb

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • anti-CD30
Active Comparator: Standard of care
Gemcitabine
Drug: MDX-060
anti-CD30 monoclonal antibody, i.v. weekly x 3 10 mg/kg
Other Names:
  • anti-CD30

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall response rate
Time Frame: Day 50/57
Day 50/57

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Medarex Medical Monitor, Medarex

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

January 30, 2006

First Submitted That Met QC Criteria

January 30, 2006

First Posted (Estimate)

February 1, 2006

Study Record Updates

Last Update Posted (Estimate)

October 12, 2015

Last Update Submitted That Met QC Criteria

September 23, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDX060-05/05E

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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