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Phase II Study of Immunization With PSMA Peptide-Pulsed Autologous PBMC Plus rhIL-12 in Patients With Metastatic Prostate Cancer
RATIONALE: Vaccines made from a patient's white blood cells may make the body build an immune response to kill cancer cells. Interleukin-12 may kill cancer cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells. Combining vaccine therapy with interleukin-12 may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy combined with interleukin-12 in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
OBJECTIVES: * 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 unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 37 weeks.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Start Date
November 1, 2001
Primary Completion Date
March 1, 2003
Completion Date
January 1, 2005
Last Updated
March 7, 2014
13
ACTUAL participants
PSA prostate cancer vaccine
BIOLOGICAL
recombinant interleukin-12
BIOLOGICAL
Lead Sponsor
University of Chicago
Collaborators
NCT05691465
NCT04550494
Data Source & Attribution
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