|
Phase II Study of MDX-010 in Stage IV Breast Cancer Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Phase II Study of MDX-010 in Stage IV Breast Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Phase II Study of MDX-010 in Stage IV Breast Cancer Clinical research trials and Phase II Study of MDX-010 in Stage IV Breast Cancer health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Phase II Study of MDX-010 in Stage IV Breast Cancer. Phase II Study of MDX-010 in Stage IV Breast Cancer Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Phase II Study of MDX-010 in Stage IV Breast Cancer clinical trial. Human subjects often get the best healthcare available for their Phase II Study of MDX-010 in Stage IV Breast Cancer condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
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 Breast Cancer Studies:
1. Evaluation of the Addition of Herceptin to Standard Chemotherapy in the Neoadjuvant Setting for Operable Breast Cancer
2. Whole Body Hyperthermia Combined With Chemotherapy in Treating Patients With Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer
3. A Phase I Trial of Continuous Infusion UCN-01 in Patients with Refractory Neoplasms
4. Treating Inoperable Lung Tumors With Heated Chemotherapy Medicine Delivered Solely to the Lung
5. A Study of ALIMTA (pemetrexed) Plus Carboplatin for the Treatment of Patients with Locally Advanced or Metastatic Breast Cancer
Related Studies:
Other Breast Cancer Clinical Trials
Other Kansas Clinical Trials
Other Overland Park Clinical Trials
Phase II Study of MDX-010 in Stage IV Breast Cancer
|
|
|
|
|
|
|
|
