Comparison Study of MDX-010 (CTLA-4) Alone and Combined With Docetaxel in the Treatment of Patients With Hormone Refractory Prostate Cancer

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

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

Key facts

Study ID

NCT00050596

Run by

Bristol-Myers Squibb

Starts

2002-11-01

Expected to finish

2004-11-01

Last updated by the study team

2011-06-27

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Advanced Clinical Therapeutics — Tucson, Arizona, United States
• Pacific Shores Medical Group — Long Beach, California, United States
• San Diego Uro-Research — San Diego, California, United States
• LSU Health Science Center/ Stanley S. Scott Cancer Center (uptown campus) — New Orleans, Louisiana, United States
• Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• University Urological Research Institute — Providence, Rhode Island, United States
• Grand Strand Urology — Myrtle Beach, South Carolina, United States
• Urology Associates of North Texas — Arlington, Texas, United States
• Utah Cancer Specialists — Salt Lake City, Utah, United States
• Salt Lake Research — Salt Lake City, Utah, United States
• Seattle Cancer Center Alliance — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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