Status:
COMPLETED
A Phase II Study of MDX-060 in Subjects With Relapsed or Refractory Hodgkin's Disease
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Hodgkin's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
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-r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00284804
Start Date
November 1 2005
End Date
October 1 2009
Last Update
October 12 2015
Active Locations (17)
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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
La Jolla, California, United States, 92093-0698
4
H. Lee Moffitt Cancer & Research Institute
Tampa, Florida, United States, 33612