This is a randomized, multicenter, single blind, Phase 2 trial of immunotherapy in men with metastatic androgen independent prostate cancer to evaluate sipuleucel-T manufactured with different concentrations of PA2024 antigen
This is a randomized, multicenter, single blind, Phase 2 trial of immunotherapy in men with metastatic androgen independent prostate cancer to evaluate sipuleucel-T manufactured with 1 of 3 different concentrations of PA2024 antigen The primary purpose of this study is to compare the changes in CD54 upregulation between each of these 3 groups of subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
122
Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF)
UCSD Moores Cancer Center
La Jolla, California, United States
Sharp Clinical Oncology Research
San Diego, California, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Cumulative CD54 Upregulation Ratio Between Each of the Cohorts.
An analysis of variance model for the log transformed cumulative CD54 upregulation ratio (CD54 upregulation is the fold increase in the final product (FP) from buoyant density separations (BDS) step 65. BDS65 step refers to sample taken after both BDS77 and BDS65 but before ex vivo culture in the presence of antigen PA2024. FP refers to sample taken after ex vivo culture) that includes the antigen concentration cohort as the independent variable was performed. Subjects who received all 3 infusions were included.
Time frame: Baseline, Months 2, 4 and 6.
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Indiana University
Indianapolis, Indiana, United States
Mount Sinai School of Medicine
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Providence Medical Center
Portland, Oregon, United States
Kaiser Permanente
Portland, Oregon, United States
Northwest Cancer Specialists
Portland, Oregon, United States
Urology of Virginia, Sentara Medical Group
Norfolk, Virginia, United States
...and 2 more locations