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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT00284804
Collaborator
(none)
74
Enrollment
17
Locations
2
Arms
47
Duration (Months)
4.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
74 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date :
Nov 1, 2005
Actual Primary Completion Date :
May 1, 2008
Actual Study Completion Date :
Oct 1, 2009

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall response rate [Day 50/57]

    Secondary Outcome Measures

    1. Progression-free survival [Day 50/57]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 City of Hope, National Medical Center Duarte California United States 91010
    2 California Oncology of the Central Valley Fresno California United States 93710
    3 University of California, San Diego/Moores UCSD Cancer Center LaJolla California United States 92093-0698
    4 H. Lee Moffitt Cancer & Research Institute Tampa Florida United States 33612
    5 Rush Cancer Institute Chicago Illinois United States 60612
    6 St. Francis Hospital Center Beech Grove Indiana United States 46107
    7 American Health Network of Indiana Indianapolis Indiana United States 46237
    8 Division of Hematology/Oncology, Tufts-New England Medical Center Boston Massachusetts United States 02111
    9 Henry Ford Health System Detroit Michigan United States 48202
    10 Mayo Clinic Rochester Minnesota United States 55905
    11 Nevada Cancer Institute Las Vegas Nevada United States 89135
    12 The Cancer Institute of New Jersey New Brunswick New Jersey United States 08901
    13 Roswell Park Cancer Center Buffalo New York United States 14263
    14 Mount Sinai School of Medicine New York New York United States 10029
    15 Carolina BioOncology Institute, PLLC Huntersville North Carolina United States 28078
    16 M.D. Anderson Cancer Center, The University of Texas Houston Texas United States 77030
    17 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT00284804
    Other Study ID Numbers:
    • MDX060-05/05E
    First Posted:
    Feb 1, 2006
    Last Update Posted:
    Oct 12, 2015
    Last Verified:
    Sep 1, 2015
    Keywords provided by Bristol-Myers Squibb
    relapsed or refractory Hodgkin's Disease
    Additional relevant MeSH terms:
    Hodgkin Disease

    Study Results

    No Results Posted as of Oct 12, 2015