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Withdrawn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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2002-08-06
• Study First Submitted QC: 2002-08-07
• Study First Posted: 2002-08-08
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-30
• Last Update Posted: 2013-05-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (16)

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States

Albany Regional Cancer Center; 🇺🇸 Albany, New York, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Highlands Oncology Group; 🇺🇸 Springdale, Arkansas, United States

Cancer Centers of Florida, P.A.; 🇺🇸 Orlando, Florida, United States

St. Francis Medical Center; 🇺🇸 Peoria, Illinois, United States

Cancer Care Northwest; 🇺🇸 Spokane, Washington, United States

Louisiana State University; 🇺🇸 New Orleans, Louisiana, United States

Clinical Research Solutions; 🇺🇸 Las Vegas, Nevada, United States

Mary Crowley Medical Research Center; 🇺🇸 Dallas, Texas, United States

Tyler Cancer Center; 🇺🇸 Tyler, Texas, United States

Carolinas HealthCare System; 🇺🇸 Charlotte, North Carolina, United States

Walter Reed Army Medical Center; 🇺🇸 Washington, District of Columbia, United States

University of California, San Diego Medical Center; 🇺🇸 San Diego, California, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

St. Luke's Medical Center; 🇺🇸 Milwaukee, Wisconsin, United States