Prostate Cancer Clinical Trial
Official title:
A Phase I Safety Study Of Xcellerate In Patients With Hormone Refractory Prostate Cancer
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop
tumor cells from growing. Treating a person's T cells in the laboratory and then reinfusing
them may cause a stronger immune response and kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of T-cell therapy in treating patients who
have prostate cancer that has not responded to hormone therapy.
OBJECTIVES:
- Determine the safety of activated autologous T cells (Xcellerate) therapy in patients
with hormone-refractory prostate cancer.
- Determine the change in prostate-specific antigen (PSA) levels in patients treated with
this therapy.
- Determine the effects on bone in patients treated with this therapy.
OUTLINE: This is a multicenter study.
Patients undergo leukapheresis to collect peripheral blood mononuclear cells (PBMC). PBMC
are activated and expanded ex vivo by costimulation with antihuman CD3 and antihuman CD28
monoclonal antibodies covalently attached to superparamagnetic microbeads (Xcellerate).
Xcellerate-activated T cells are reinfused on day 0.
Patients are followed weekly for 4 weeks and then monthly for 3 months.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.
;
Primary Purpose: Treatment
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