Phase II Study of Immunization With PSMA Peptide-Pulsed Autologous PBMC Plus rhIL-12 in Patients With Metastatic Prostate Cancer
- Determine whether immunization with prostate-specific membrane antigen-pulsed
autologous peripheral blood mononuclear cells and interleukin-12 can promote specific
T-cell priming in patients with metastatic hormone-refractory prostate cancer.
- Determine the clinical response in patients treated with this regimen.
OUTLINE: Patients receive prostate-specific membrane antigen-pulsed autologous peripheral
blood mononuclear cells subcutaneously (SC) on day 1 and interleukin-12 SC on days 1, 3, and
5. Treatment repeats every 21 days for 3-9 courses in the absence of disease progression or
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 37 weeks.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Thomas F. Gajewski, MD, PhD
University of Chicago
United States: Federal Government
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|