Back to resultsComparison Study of MDX-010 (CTLA-4) Alone and Combined With Docetaxel in the Treatment of Patients With Hormone Refractory Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MDX-010 / MDX-010 + Docetaxel
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility 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.
Sites / Locations
- Advanced Clinical Therapeutics
- Pacific Shores Medical Group
- San Diego Uro-Research
- LSU Health Science Center/ Stanley S. Scott Cancer Center (uptown campus)
- Milton S. Hershey Medical Center
- University Urological Research Institute
- Grand Strand Urology
- Urology Associates of North Texas
- Utah Cancer Specialists
- Salt Lake Research
- Seattle Cancer Center Alliance
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00050596
Brief Title
Comparison Study of MDX-010 (CTLA-4) Alone and Combined With Docetaxel in the Treatment of Patients With Hormone Refractory Prostate Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
November 2004 (Actual)
Study Completion Date
November 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MDX-010 / MDX-010 + Docetaxel
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Advanced Clinical Therapeutics
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Pacific Shores Medical Group
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
San Diego Uro-Research
City
San Diego
State/Province
California
ZIP/Postal Code
92101
Country
United States
Facility Name
LSU Health Science Center/ Stanley S. Scott Cancer Center (uptown campus)
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
University Urological Research Institute
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Grand Strand Urology
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Urology Associates of North Texas
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Salt Lake Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Seattle Cancer Center Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1023
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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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