An Open-Label Multicenter Study of Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer Patients Previously Treated With Sipuleucel-T on Dendreon Study P-11 (NCT00779402)
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the immune response generated by sipuleucel-T
Antigen-specific T cell responses will be assessed by mean of a proliferation assay and an interferon-gamma enzyme-linked immunospot (ELISPOT) assay. Antigen-specific humoral immune responses will be measured by means of an enzyme-linked immunosorbent assay (ELISA)
Change in immune response from Baseline through Month 12
No
Robert Sims, MD
Study Director
Dendreon
United States: Food and Drug Administration
P10-1
NCT01338012
November 2011
Name | Location |
---|---|
University of Colorado Cancer Center | Denver, Colorado 80262 |
Virginia Mason Medical Center | Seattle, Washington 98111 |
Oregon Health & Science University | Portland, Oregon 97201 |
South Orange County Medical Research Center | Laguna Hills, California 92653 |
Urology of Virginia | Newport News, Virginia 23606 |
Virginia Mason Hospital | Seattle, Washington 98101 |