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| Sponsor: | Northwest Biotherapeutics |
|---|---|
| Information provided by: | Northwest Biotherapeutics |
| ClinicalTrials.gov Identifier: | NCT00043212 |
Purpose
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.
Eligibility| 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
Contacts and Locations| 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 | |
More Information
| Study ID Numbers: | DC3-HRPC, October 2001 |
| Study First Received: | August 6, 2002 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00043212 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
prostate cancer oncology urology hormone refractory prostate cancer |
|
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Urogenital Neoplasms Genital Diseases, Male Hormones Prostatic Neoplasms Pharmacologic Actions |