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

Primary Purpose

Hodgkin's Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MDX-060
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hodgkin's Disease focused on measuring relapsed or refractory Hodgkin's Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope, National Medical Center
  • California Oncology of the Central Valley
  • University of California, San Diego/Moores UCSD Cancer Center
  • H. Lee Moffitt Cancer & Research Institute
  • Rush Cancer Institute
  • St. Francis Hospital Center
  • American Health Network of Indiana
  • Division of Hematology/Oncology, Tufts-New England Medical Center
  • Henry Ford Health System
  • Mayo Clinic
  • Nevada Cancer Institute
  • The Cancer Institute of New Jersey
  • Roswell Park Cancer Center
  • Mount Sinai School of Medicine
  • Carolina BioOncology Institute, PLLC
  • M.D. Anderson Cancer Center, The University of Texas
  • Mary Babb Randolph Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MDX-060 plus standard of care

Standard of care

Arm Description

MDX-060 in combination with gemcitabine

Gemcitabine

Outcomes

Primary Outcome Measures

Overall response rate

Secondary Outcome Measures

Progression-free survival

Full Information

First Posted
January 30, 2006
Last Updated
September 23, 2015
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00284804
Brief Title
A Phase II Study of MDX-060 in Subjects With Relapsed or Refractory Hodgkin's Disease
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 Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

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-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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin's Disease
Keywords
relapsed or refractory Hodgkin's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MDX-060 plus standard of care
Arm Type
Experimental
Arm Description
MDX-060 in combination with gemcitabine
Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
Gemcitabine
Intervention Type
Drug
Intervention Name(s)
MDX-060
Other Intervention Name(s)
anti-CD30
Intervention Description
anti-CD30 monoclonal antibody, i.v. weekly x 3 10 mg/kg
Primary Outcome Measure Information:
Title
Overall response rate
Time Frame
Day 50/57
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
Day 50/57

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medarex Medical Monitor
Organizational Affiliation
Medarex
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope, National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
California Oncology of the Central Valley
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
University of California, San Diego/Moores UCSD Cancer Center
City
LaJolla
State/Province
California
ZIP/Postal Code
92093-0698
Country
United States
Facility Name
H. Lee Moffitt Cancer & Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Rush Cancer Institute
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
St. Francis Hospital Center
City
Beech Grove
State/Province
Indiana
ZIP/Postal Code
46107
Country
United States
Facility Name
American Health Network of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Division of Hematology/Oncology, Tufts-New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Nevada Cancer Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Facility Name
The Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Roswell Park Cancer Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Carolina BioOncology Institute, PLLC
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
M.D. Anderson Cancer Center, The University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Mary Babb Randolph Cancer Center
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506-9162
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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