Clinical trial NCT00083278: Study of MDX-010 in Stage IV Breast Cancer
Official title: A Phase II Study of MDX-010 in Patients With Stage IV Adenocarcinoma of the Breast
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Adenocarcinoma
Keywords: Breast Cancer
Stage IV adenocarcinoma of the breast
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2004-05-20
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sharp Clinical Oncology Research
state: California
city: Indianapolis
country: United States
facility: Wishard Health Services
state: Indiana
city: Indianapolis
country: United States
facility: Section of Hematology/Oncology, Indiana Cancer Pavilion
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University, Clarian Health Partners
state: Indiana
city: Jeffersonville
country: United States
facility: Medical Arts Building
state: Indiana
city: Kansas City
country: United States
facility: Kansas City Oncology and Hematology Group
state: Kansas
city: Overland Park
country: United States
facility: Kansas City Oncology and Hematology Group
state: Kansas
city: LaGrange
country: United States
facility: LaGrange
state: Kentucky
city: Louisville
country: United States
facility: Norton Healthcare Inc, Loiusville Oncology Clinical Research Program
state: Kentucky
city: Louisville
country: United States
facility: Suburban Medical Plaza II
state: Kentucky
city: Louisville
country: United States
facility: Audubon Oncology/Hematology
state: Kentucky
city: Kansas City
country: United States
facility: Kansas City Oncology and Hematology Group
state: Missouri
city: Lee's Summit
country: United States
facility: Kansas City Oncology and Hematology Group
state: Missouri
city: Arlington
country: United States
facility: Arlington Cancer Center
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: