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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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00050596
First received: December 16, 2002
Last updated: June 23, 2011
Last verified: June 2011
History of Changes
  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
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:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:
Study Start Date: November 2002
Study Completion Date: November 2004
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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

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
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
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00050596     History of Changes
Other Study ID Numbers: MDX010-07
CA184-019 ( Other Identifier: BMS )
Study First Received: December 16, 2002
Last Updated: June 23, 2011

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Hormones
 Antibodies, Monoclonal
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunologic Factors

ClinicalTrials.gov processed this record on May 23, 2017