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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00284804
Recruitment Status : Completed
First Posted : February 1, 2006
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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
Hodgkin's Disease Drug: MDX-060 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

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Study Type : Interventional  (Clinical Trial)
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 : November 2005
Actual Primary Completion Date : May 2008
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hodgkin Disease

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 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




Primary Outcome Measures :
  1. Overall response rate [ Time Frame: Day 50/57 ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: Day 50/57 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00284804


Locations
Show Show 17 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Medarex Medical Monitor Medarex
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00284804    
Other Study ID Numbers: MDX060-05/05E
First Posted: February 1, 2006    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: September 2015
Keywords provided by Bristol-Myers Squibb:
relapsed or refractory Hodgkin's Disease
Additional relevant MeSH terms:
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Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases