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

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ClinicalTrials.gov Identifier: NCT00050596
Recruitment Status : Completed
First Posted : December 17, 2002
Last Update Posted : June 27, 2011
Sponsor:
Information provided by:
Bristol-Myers Squibb

Study Description
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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

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: MDX-010 / MDX-010 + Docetaxel Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : November 2002
Actual Primary Completion Date : November 2004
Actual Study Completion Date : November 2004

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00050596


Locations
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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
Utah Cancer Specialists
Salt Lake City, Utah, United States, 84106
Salt Lake Research
Salt Lake City, Utah, United States, 84124
United States, Washington
Seattle Cancer Center Alliance
Seattle, Washington, United States, 98109-1023
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00050596    
Other Study ID Numbers: MDX010-07
CA184-019 ( Other Identifier: BMS )
First Posted: December 17, 2002    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: June 2011
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Docetaxel
 Ipilimumab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological