Comparison Study of MDX-010 (CTLA-4) Alone and Combined With Docetaxel in the Treatment of Patients With Hormone Refractory Prostate Cancer
- Conditions
- Prostate Cancer
- Registration Number
- NCT00050596
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The primary objectives of the study are to determine the safety and activity of multiple doses of MDX-010 in patients with hormone-refractory prostate cancer (HRPC), and to determine the safety and activity profile of a single dose of cytotoxic chemotherapy (docetaxel) in combination with MDX-010
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- Not specified
- Clinical diagnosis of adenocarcinoma of the prostate.
- Metastatic prostate cancer (positive bone scan or measurable disease).
- Progressive disease after androgen deprivation.
- No prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor given to control prostate cancer).
- Other prior malignancy, except for adequately treated basal or squamous cell skin cancer or superficial bladder cancer, or any other cancer from which the patient has been disease-free for greater than or equal to 5 years.
- Previous occurrence of autoimmune disease.
- Active infection requiring therapy including HIV or chronic hepatitis.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
University Urological Research Institute
🇺🇸Providence, Rhode Island, United States
Pacific Shores Medical Group
🇺🇸Long Beach, California, United States
San Diego Uro-Research
🇺🇸San Diego, California, United States
Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Urology Associates of North Texas
🇺🇸Arlington, Texas, United States
Seattle Cancer Center Alliance
🇺🇸Seattle, Washington, United States
Utah Cancer Specialists
🇺🇸Salt Lake City, Utah, United States
Grand Strand Urology
🇺🇸Myrtle Beach, South Carolina, United States
Advanced Clinical Therapeutics
🇺🇸Tucson, Arizona, United States
LSU Health Science Center/ Stanley S. Scott Cancer Center (uptown campus)
🇺🇸New Orleans, Louisiana, United States
Salt Lake Research
🇺🇸Salt Lake City, Utah, United States