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Study of MDX-010 in Stage IV Breast Cancer
This study has been completed.
Sponsored by: Medarex
Information provided by: Medarex
ClinicalTrials.gov Identifier: NCT00083278
  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 II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Ipilimumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Efficacy Study
Official Title: A Phase II Study of MDX-010 in Patients With Stage IV Adenocarcinoma of the Breast

Further study details as provided by Medarex:

Estimated Enrollment: 33
Study Start Date: May 2003
  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
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
Medical Arts Building
Jeffersonville, Indiana, United States, 47130
Section of Hematology/Oncology, Indiana Cancer Pavilion
Indianapolis, Indiana, United States, 46202-5289
Indiana University, Clarian Health Partners
Indianapolis, Indiana, United States, 46202
Wishard Health Services
Indianapolis, Indiana, United States, 46202-2859
United States, Kansas
Kansas City Oncology and Hematology Group
Overland Park, Kansas, United States, 66210
Kansas City Oncology and Hematology Group
Kansas City, Kansas, United States, 66112
United States, Kentucky
Norton Healthcare Inc, Loiusville Oncology Clinical Research Program
Louisville, Kentucky, United States, 40202
Suburban Medical Plaza II
Louisville, Kentucky, United States, 40207
Audubon Oncology/Hematology
Louisville, Kentucky, United States, 40217
LaGrange
LaGrange, Kentucky, United States, 40031
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
Medarex
  More Information

Study ID Numbers: MDX010-12
Study First Received: May 17, 2004
Last Updated: February 27, 2007
ClinicalTrials.gov Identifier: NCT00083278  
Health Authority: United States: Food and Drug Administration

Keywords provided by Medarex:
Breast Cancer
Stage IV adenocarcinoma of the breast

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms
Adenocarcinoma
Breast Diseases
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 15, 2009