Study of MDX-010 in Stage IV Breast Cancer

April 26, 2012 updated by: Bristol-Myers Squibb

A Phase II Study of MDX-010 in Patients With Stage IV Adenocarcinoma of the Breast

This Phase II study is designed to treat patients who have been diagnosed with Stage IV Breast Cancer, which has progressed despite treatment with primary therapies, including hormonal therapy, chemotherapy, and antibody therapy. Thirty-three patients will be treated with the monoclonal antibody MDX-010. The initial antitumor activity profile of MDX-010 will be determined, as well as identification of the induction of any antitumor immunity following the MDX-010 treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92123
        • Sharp Clinical Oncology Research
    • Indiana
      • Indianapolis, Indiana, United States, 46202-2859
        • Wishard Health Services
      • Indianapolis, Indiana, United States, 46202-5289
        • Section of Hematology/Oncology, Indiana Cancer Pavilion
      • Indianapolis, Indiana, United States, 46202
        • Indiana University, Clarian Health Partners
      • Jeffersonville, Indiana, United States, 47130
        • Medical Arts Building
    • Kansas
      • Kansas City, Kansas, United States, 66112
        • Kansas City Oncology and Hematology Group
      • Overland Park, Kansas, United States, 66210
        • Kansas City Oncology and Hematology Group
    • Kentucky
      • LaGrange, Kentucky, United States, 40031
        • LaGrange
      • Louisville, Kentucky, United States, 40202
        • Norton Healthcare Inc, Loiusville Oncology Clinical Research Program
      • Louisville, Kentucky, United States, 40207
        • Suburban Medical Plaza II
      • Louisville, Kentucky, United States, 40217
        • Audubon Oncology/Hematology
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • Kansas City Oncology and Hematology Group
      • Lee's Summit, Missouri, United States, 64064
        • Kansas City Oncology and Hematology Group
    • Texas
      • Arlington, Texas, United States, 76012
        • Arlington Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Provide written informed consent
  • diagnosed with Stage IV adenocarcinoma that has progressed despite previous therapy
  • at least 18 years of age
  • measurable disease defined by RECIST
  • must discontinue any alternative therapy used to treat breast cancer at least 4 weeks prior to enrollment and agree to not use such therapies during the duration of the study (patients may continue to receive tamoxifen, bisphosphate therapy and trastuzumab)
  • prior radiation must be completed at least 4 weeks prior to enrollment
  • ECOG performance status of 0-2
  • Negative pregnancy test
  • Screening lab values must be met

Exclusion Criteria:

  • must be disease free from other cancers for at least 5 years
  • symptomatic or untreated brain metastases
  • active or history of autoimmune disease
  • active HIV, HTLV, HBV or HCV infection
  • concurrent medical condition requiring the use of systemic corticosteroids, must be discontinued at least 4 weeks prior to enrollment
  • prior therapy with anti-CTLA-4 antibody
  • significant organ compromise, uncontrolled heart, liver, lung, or renal disease or other serious illness
  • pregnancy or nursing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Study Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

May 17, 2004

First Submitted That Met QC Criteria

May 19, 2004

First Posted (Estimate)

May 20, 2004

Study Record Updates

Last Update Posted (Estimate)

April 27, 2012

Last Update Submitted That Met QC Criteria

April 26, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDX010-12
  • CA184-015 (Other Identifier: BMS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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