Study of MDX-010 in Stage IV Breast Cancer

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT00083278

Collaborator

(none)

Enrollment

Locations

33.1

Duration (Months)

2.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Breast Cancer Adenocarcinoma	Drug: MDX-010	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

Non-Randomized

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2003

Actual Study Completion Date :

Feb 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Sharp Clinical Oncology Research	San Diego	California	United States	92123
2	Wishard Health Services	Indianapolis	Indiana	United States	46202-2859
3	Section of Hematology/Oncology, Indiana Cancer Pavilion	Indianapolis	Indiana	United States	46202-5289
4	Indiana University, Clarian Health Partners	Indianapolis	Indiana	United States	46202
5	Medical Arts Building	Jeffersonville	Indiana	United States	47130
6	Kansas City Oncology and Hematology Group	Kansas City	Kansas	United States	66112
7	Kansas City Oncology and Hematology Group	Overland Park	Kansas	United States	66210
8	LaGrange	LaGrange	Kentucky	United States	40031
9	Norton Healthcare Inc, Loiusville Oncology Clinical Research Program	Louisville	Kentucky	United States	40202
10	Suburban Medical Plaza II	Louisville	Kentucky	United States	40207
11	Audubon Oncology/Hematology	Louisville	Kentucky	United States	40217
12	Kansas City Oncology and Hematology Group	Kansas City	Missouri	United States	64131
13	Kansas City Oncology and Hematology Group	Lee's Summit	Missouri	United States	64064
14	Arlington Cancer Center	Arlington	Texas	United States	76012