A Phase II Study of MDX-060 in Subjects With Relapsed or Refractory Hodgkin's Disease
This study has been completed.
Sponsor:
Bristol-Myers Squibb
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
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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
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 May 16, 2013