Prostate Cancer Clinical Trial
Official title:
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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