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Home > "P" Clinical Trials Conditions > Phase II Study of MDX-010 in Stage IV Breast Cancer  Phase II Study of MDX-010 in Stage IV Breast Cancer
Phase II Study of MDX-010 in Stage IV Breast Cancer
For Condition: Adenocarcinoma,Breast Cancer
Status: Recruiting
Sponsor(s): Medarex ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Female
Protocol Entry 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 recieve 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 metstases - 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, unconrolled heart, liver, lung, or renal disease or other serious illness - pregnancy or nursing
Total Enrollment: 33
Location and Contact Information:
Norton Healthcare Inc, Loiusville Oncology Clinical Research Program *Recruiting*
Louisville, Kentucky, 40202
United States
Recruiting John Hamm
Section of Hematology/Oncology, Indiana Cancer Pavilion *Recruiting*
Indianapolis, Indiana, 46202-5289
United States
Recruiting Kathy Miller
Kansas City Oncology and Hematology Group *Recruiting*
Overland Park, Kansas, 66210
United States
Recruiting Kelly Pendergrass
Suburban Medical Plaza II *Recruiting*
Louisville, Kentucky, 40207
United States
Recruiting John Hamm
LaGrange *Recruiting*
Lagrange, Kentucky, 40031
United States
Recruiting John Hamm
Arlington Cancer Center *Recruiting*
Arlington, Texas, 76012
United States
Recruiting Alfred DiStefano
Kansas City Oncology and Hematology Group *Recruiting*
Lees Summit, Missouri, 64064
United States
Recruiting Kelly Pendergrass
Medical Arts Building *Recruiting*
Jeffersonville, Indiana, 47130
United States
Recruiting John Hamm
Kansas City Oncology and Hematology Group *Recruiting*
Kansas City, Kansas, 66112
United States
Recruiting Kelly Pendergrass
Audubon Oncology/Hematology *Recruiting*
Louisville, Kentucky, 40217
United States
Recruiting John Hamm
Indiana University, Clarian Health Partners *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Kathy Miller
Wishard Health Services *Recruiting*
Indianapolis, Indiana, 46202-2859
United States
Recruiting Kathy Miller
Sharp Clinical Oncology Research *Recruiting*
San Diego, California, 92123
United States
Recruiting Shankar Sundaram
Kansas City Oncology and Hematology Group *Recruiting*
Kansas City, Missouri, 64131
United States
Recruiting Kelly Pendergrass
Additional Information:
Study ID Numbers: MDX010-12;
Study Start Date: May 2003
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00083278
Other Adenocarcinoma Studies:
1. A Phase I Trial of Tamoxifen and 9-cis-Retinoic Acid in Breast Cancer Patients
2. Gabapentin For the Control of Hot Flashes in Women With Breast Cancer
3. Phase I/II Trial of Doxil and Hyperthermia for Breast Cancer Patients with Chest Wall Recurrence or Stage IV Disease with Locally Advanced Breast Cancer
4. Ribavirin With or Without Monoclonal Antibody Therapy in Treating Patients Who Develop RSV Pneumonia Following Peripheral Stem Cell Transplantation
5. Efficacy and Safety of SU-011,248 in Patients with Anthracycline- and Taxane-Refractory Metastatic Breast Cancer
Related Studies:
Other Adenocarcinoma Clinical Trials
Other Kansas Clinical Trials
Other Kansas City Clinical Trials
Phase II Study of MDX-010 in Stage IV Breast Cancer
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