Study of MDX-010 in Stage IV Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00083278
First received: May 17, 2004
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Adenocarcinoma
Drug: MDX-010
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of MDX-010 in Patients With Stage IV Adenocarcinoma of the Breast

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Enrollment: 33
Study Start Date: May 2003
Study Completion Date: February 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00083278

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

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00083278     History of Changes
Other Study ID Numbers: MDX010-12, CA184-015
Study First Received: May 17, 2004
Last Updated: April 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Breast Cancer
Stage IV adenocarcinoma of the breast

Additional relevant MeSH terms:
Adenocarcinoma
Breast Neoplasms
Breast Diseases
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014