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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


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

MDX010-07

NCT ID:

NCT00050596

Start Date:

November 2002

Completion Date:

November 2004

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
Urology Associates of North TexasArlington, Texas  76015
Pacific Shores Medical GroupLong Beach, California  90813
Grand Strand UrologyMyrtle Beach, South Carolina  29572
Salt Lake ResearchSalt Lake City, Utah  84124
University Urological Research InstituteProvidence, Rhode Island  02904
Utah Cancer SpecialistsSalt Lake City, Utah  84106
Advanced Clinical TherapeuticsTucson, Arizona  85712
San Diego Uro-ResearchSan Diego, California  92101
LSU Health Science Center/ Stanley S. Scott Cancer Center (uptown campus)New Orleans, Louisiana  70112
Seattle Cancer Center AllianceSeattle, Washington  98109-1023