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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00050596
• Other study ID #: MDX010-07
• Secondary ID: CA184-019
• Status: Completed
• Phase: Phase 2
• First received: December 16, 2002
• Last updated: June 23, 2011
• Start date: November 2002
• Est. completion date: November 2004

Study information

• Verified date: June 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: November 2004
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• MDX-010 / MDX-010 + Docetaxel

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm