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

NCT ID: NCT00050596

Last Updated: 2011-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2004-11-30

Brief Summary

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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

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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MDX-010 / MDX-010 + Docetaxel

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Bristol-Myers Squibb

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Advanced Clinical Therapeutics

Tucson, Arizona, United States

Site Status

Pacific Shores Medical Group

Long Beach, California, United States

Site Status

San Diego Uro-Research

San Diego, California, United States

Site Status

LSU Health Science Center/ Stanley S. Scott Cancer Center (uptown campus)

New Orleans, Louisiana, United States

Site Status

Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

University Urological Research Institute

Providence, Rhode Island, United States

Site Status

Grand Strand Urology

Myrtle Beach, South Carolina, United States

Site Status

Urology Associates of North Texas

Arlington, Texas, United States

Site Status

Utah Cancer Specialists

Salt Lake City, Utah, United States

Site Status

Salt Lake Research

Salt Lake City, Utah, United States

Site Status

Seattle Cancer Center Alliance

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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CA184-019

Identifier Type: OTHER

Identifier Source: secondary_id

MDX010-07

Identifier Type: -

Identifier Source: org_study_id

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