An Open Label Study of Sipuleucel-T in Men With Metastatic Castrate Resistant Prostate Cancer
Subjects will receive the investigational product, sipuleucel-T, at approximately 2-week
intervals, for a total of 3 infusions. The study will evaluate the safety of and magnitude
of the immune responses to treatment with sipuleucel-T. All subjects will be followed for 30
days following the last infusion of sipuleucel-T. The study is also available to placebo
subjects who participated in the D9902B study.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate the magnitude of immune responses to treatment with sipuleucel-T
2010
No
United States: Food and Drug Administration
P09-1
NCT00901342
August 2009
December 2013
Name | Location |
---|---|
NYU Cancer Institute | New York, New York 10016 |
The University of Chicago Medical Center | Chicago, Illinois 60637-1470 |
Georgetown University Medical Center | Washington, District of Columbia 20007 |
Oncology Specialists, S.C. | Park Ridge, Illinois 60068 |
Columbia University Medical Center | New York, New York 10032 |
Maine Center for Cancer Medicine | Scarborough, Maine 04074 |
Sarah Cannon Research Institute | Nashville, Tennessee 37203 |
Virginia Mason Medical Center Urology and Renal Transplantation | Seattle, Washington 98101 |
Indiana University Department of Urology | Indianapolis, Indiana 46202 |
Myron I. Murdock MD LLC | Greenbelt, Maryland 20770 |
Hematology Oncology Consultants | Greenbelt, Maryland 20770 |
Mount Sinai School of Medicine Department of Urology | New York, New York 10029 |
GU Oncology Research Program | Durham, North Carolina 27710 |
Texas Oncology, PA - Sammons Cancer Center | Dallas, Texas 75246 |
Urology of Virginia/ Sentara | Norfolk, Virginia 23502 |
Aurora Advanced Healthcare, Inc | Wauwatosa, Wisconsin 53226 |