Comparison Study of MDX-010 (CTLA-4) Alone and Combined With Docetaxel in the Treatment of Patients With Hormone Refractory Prostate Cancer
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00050596
First received: December 16, 2002
Last updated: June 23, 2011
Last verified: June 2011
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: MDX-010 / MDX-010 + Docetaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00050596
Please refer to this study by its ClinicalTrials.gov identifier: NCT00050596
Locations
| United States, Arizona | |
| Advanced Clinical Therapeutics | |
| Tucson, Arizona, United States, 85712 | |
| United States, California | |
| Pacific Shores Medical Group | |
| Long Beach, California, United States, 90813 | |
| San Diego Uro-Research | |
| San Diego, California, United States, 92101 | |
| United States, Louisiana | |
| LSU Health Science Center/ Stanley S. Scott Cancer Center (uptown campus) | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Pennsylvania | |
| Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033 | |
| United States, Rhode Island | |
| University Urological Research Institute | |
| Providence, Rhode Island, United States, 02906 | |
| United States, South Carolina | |
| Grand Strand Urology | |
| Myrtle Beach, South Carolina, United States, 29572 | |
| United States, Texas | |
| Urology Associates of North Texas | |
| Arlington, Texas, United States, 76012 | |
| United States, Utah | |
| Salt Lake Research | |
| Salt Lake City, Utah, United States, 84124 | |
| Utah Cancer Specialists | |
| Salt Lake City, Utah, United States, 84106 | |
| United States, Washington | |
| Seattle Cancer Center Alliance | |
| Seattle, Washington, United States, 98109-1023 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Study Director, Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00050596 History of Changes |
| Other Study ID Numbers: | MDX010-07, CA184-019 |
| Study First Received: | December 16, 2002 |
| Last Updated: | June 23, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Diseases, Male Genital Neoplasms, Male Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Neoplasms Docetaxel |
Antimitotic Agents Antineoplastic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses Tubulin Modulators |
ClinicalTrials.gov processed this record on March 01, 2015