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.

Sponsored by:	Medarex
Information provided by:	Medarex
ClinicalTrials.gov Identifier:	NCT00050596

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 II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Docetaxel Ipilimumab Cytotoxic T-lymphocyte antigen 4

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
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

Further study details as provided by Medarex:

Study Start Date:

November 2002

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

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

Medarex

More Information

Study ID Numbers:	MDX010-07
Study First Received:	December 16, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00050596
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Docetaxel
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms

Genital Diseases, Male
Prostatic Neoplasms
Cytotoxic T-lymphocyte antigen 4

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009