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Sponsored by: |
Northwest Biotherapeutics |
---|---|
Information provided by: | Northwest Biotherapeutics |
ClinicalTrials.gov Identifier: | NCT00043212 |
The purpose of this clinical research study is to assess the safety and efficacy of an investigational therapy called DCVax(TM)-Prostate.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: Dendritic cell immunotherapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 495 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Hormone refractory prostate cancer (HRPC) – progressive disease despite androgen deprivation and serum testosterone <50ng/dL; progression defined as either:
Exclusion Criteria
United States, Arkansas | |
Highlands Oncology Group | |
Springdale, Arkansas, United States | |
United States, California | |
University of California, Los Angeles | |
Los Angeles, California, United States | |
University of California, San Diego Medical Center | |
San Diego, California, United States | |
United States, District of Columbia | |
Walter Reed Army Medical Center | |
Washington, District of Columbia, United States | |
United States, Florida | |
Cancer Centers of Florida, P.A. | |
Orlando, Florida, United States | |
United States, Illinois | |
St. Francis Medical Center | |
Peoria, Illinois, United States | |
United States, Louisiana | |
Louisiana State University | |
New Orleans, Louisiana, United States | |
United States, Nevada | |
Clinical Research Solutions | |
Las Vegas, Nevada, United States | |
United States, New York | |
Albany Regional Cancer Center | |
Albany, New York, United States | |
United States, North Carolina | |
Carolinas HealthCare System | |
Charlotte, North Carolina, United States | |
United States, Ohio | |
Cleveland Clinic Foundation | |
Cleveland, Ohio, United States | |
United States, Texas | |
Tyler Cancer Center | |
Tyler, Texas, United States | |
Mary Crowley Medical Research Center | |
Dallas, Texas, United States | |
United States, Utah | |
University of Utah | |
Salt Lake City, Utah, United States | |
United States, Washington | |
Cancer Care Northwest | |
Spokane, Washington, United States | |
United States, Wisconsin | |
St. Luke's Medical Center | |
Milwaukee, Wisconsin, United States |
Study ID Numbers: | DC3-HRPC, October 2001 |
Study First Received: | August 6, 2002 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00043212 |
Health Authority: | United States: Food and Drug Administration |
prostate cancer oncology urology hormone refractory prostate cancer |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site |