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Study of a Drug [DCVax (tm)-Prostate] to Treat Prostate Cancer When Hormone Therapy is no Longer Effective.

Phase 3
Withdrawn
Conditions
Prostate Cancer
Registration Number
NCT00043212
Lead Sponsor
Northwest Biotherapeutics
Brief Summary

The purpose of this clinical research study is to assess the safety and efficacy of an investigational therapy called DCVax(TM)-Prostate.

Detailed Description

Patients with hormone refractory prostate cancer are eligible if they have a rising PSA or three or fewer metastatic lesions. The experimental therapy uses a patient's own white blood cells and "teaches" the cells to recognize a "flag" on prostate cancer cells. This may help the immune system destroy prostate cancer cells. Side effects reported from the Phase I/II trial include skin reactions of redness, pain \& swelling at the injection site, and short-lived headache, fever \& fatigue. Full details are available in the informed consent.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
Male
Target Recruitment
Not specified
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (16)

University of California, Los Angeles

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Los Angeles, California, United States

Albany Regional Cancer Center

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Albany, New York, United States

Cleveland Clinic Foundation

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Cleveland, Ohio, United States

Highlands Oncology Group

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Springdale, Arkansas, United States

Cancer Centers of Florida, P.A.

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Orlando, Florida, United States

St. Francis Medical Center

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Peoria, Illinois, United States

Cancer Care Northwest

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Spokane, Washington, United States

Louisiana State University

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New Orleans, Louisiana, United States

Clinical Research Solutions

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Las Vegas, Nevada, United States

Mary Crowley Medical Research Center

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Dallas, Texas, United States

Tyler Cancer Center

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Tyler, Texas, United States

Carolinas HealthCare System

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Charlotte, North Carolina, United States

Walter Reed Army Medical Center

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Washington, District of Columbia, United States

University of California, San Diego Medical Center

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San Diego, California, United States

University of Utah

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Salt Lake City, Utah, United States

St. Luke's Medical Center

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Milwaukee, Wisconsin, United States

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