A Randomized Study Comparing 4 Monthly Doses of MDX-010 (CTLA-4) as a Single Agent or Used in Combination With a Single Dose of Docetaxel in Patients With Hormone-Refractory Prostate Cancer
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Male
Prostate Cancer
Male
Prostate Cancer
Trial Information
A Randomized Study Comparing 4 Monthly Doses of MDX-010 (CTLA-4) as a Single Agent or Used in Combination With a Single Dose of Docetaxel in Patients With Hormone-Refractory Prostate Cancer
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
MDX010-07
NCT ID:
NCT00050596
Start Date:
November 2002
Completion Date:
November 2004
Related Keywords:
- Prostate Cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033 |
| Urology Associates of North Texas | Arlington, Texas 76015 |
| Pacific Shores Medical Group | Long Beach, California 90813 |
| Grand Strand Urology | Myrtle Beach, South Carolina 29572 |
| Salt Lake Research | Salt Lake City, Utah 84124 |
| University Urological Research Institute | Providence, Rhode Island 02904 |
| Utah Cancer Specialists | Salt Lake City, Utah 84106 |
| Advanced Clinical Therapeutics | Tucson, Arizona 85712 |
| San Diego Uro-Research | San Diego, California 92101 |
| LSU Health Science Center/ Stanley S. Scott Cancer Center (uptown campus) | New Orleans, Louisiana 70112 |
| Seattle Cancer Center Alliance | Seattle, Washington 98109-1023 |
