A Phase II Study of MDX-060 in Subjects With Relapsed or Refractory Hodgkin's Disease
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| ClinicalTrials.gov Identifier: NCT00284804 |
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Recruitment Status :
Completed
First Posted : February 1, 2006
Last Update Posted : October 12, 2015
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
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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 |
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 (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 |
|---|---|
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Experimental: MDX-060 plus standard of care
MDX-060 in combination with gemcitabine
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Drug: MDX-060
anti-CD30 monoclonal antibody, i.v. weekly x 3 10 mg/kg
Other Name: anti-CD30 |
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Active Comparator: Standard of care
Gemcitabine
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Drug: MDX-060
anti-CD30 monoclonal antibody, i.v. weekly x 3 10 mg/kg
Other Name: anti-CD30 |
Primary Outcome Measures :
- Overall response rate [ Time Frame: Day 50/57 ]
Secondary Outcome Measures :
- 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 17 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Medarex Medical Monitor | Medarex |
| 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:
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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 |