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

Hodgkin's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00284804
• Other study ID #: MDX060-05/05E
• Status: Completed
• Phase: Phase 2
• First received: January 30, 2006
• Last updated: September 23, 2015
• Start date: November 2005
• Est. completion date: October 2009

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: October 2009
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Disease

Intervention

Drug:
• MDX-060
anti-CD30 monoclonal antibody, i.v. weekly x 3 10 mg/kg

Locations

Country	Name	City	State
United States	St. Francis Hospital Center	Beech Grove	Indiana
United States	Division of Hematology/Oncology, Tufts-New England Medical Center	Boston	Massachusetts
United States	Roswell Park Cancer Center	Buffalo	New York
United States	Rush Cancer Institute	Chicago	Illinois
United States	Henry Ford Health System	Detroit	Michigan
United States	City of Hope, National Medical Center	Duarte	California
United States	California Oncology of the Central Valley	Fresno	California
United States	M.D. Anderson Cancer Center, The University of Texas	Houston	Texas
United States	Carolina BioOncology Institute, PLLC	Huntersville	North Carolina
United States	American Health Network of Indiana	Indianapolis	Indiana
United States	University of California, San Diego/Moores UCSD Cancer Center	LaJolla	California
United States	Nevada Cancer Institute	Las Vegas	Nevada
United States	Mary Babb Randolph Cancer Center	Morgantown	West Virginia
United States	The Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Mount Sinai School of Medicine	New York	New York
United States	Mayo Clinic	Rochester	Minnesota
United States	H. Lee Moffitt Cancer & Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate		Day 50/57	No
Secondary	Progression-free survival		Day 50/57	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm