A Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial Evaluating DCVax(tm)-Prostate, Autologous Dendritic Cells Loaded With Recombinant PSMA for the Treatment of Metastatic Hormone Refractory Prostate Cancer
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
United States: Food and Drug Administration
DC3-HRPC, October 2001
NCT00043212
Name | Location |
---|---|
Louisiana State University | New Orleans, Louisiana 70112-2282 |
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
St. Luke's Medical Center | Milwaukee, Wisconsin 53215 |
Albany Regional Cancer Center | Albany, New York 12208 |
St. Francis Medical Center | Peoria, Illinois 61637 |
Highlands Oncology Group | Springdale, Arkansas 72764 |
Mary Crowley Medical Research Center | Dallas, Texas 75246 |
Tyler Cancer Center | Tyler, Texas 75702 |
University of Utah | Salt Lake City, Utah |
Cancer Care Northwest | Spokane, Washington 99202 |
University of California, Los Angeles | Los Angeles, California |
University of California, San Diego Medical Center | San Diego, California |
Cancer Centers of Florida, P.A. | Orlando, Florida |
Clinical Research Solutions | Las Vegas, Nevada |
Carolinas HealthCare System | Charlotte, North Carolina |