Prostate Cancer Clinical Trial
Official title:
A Phase II Study Of Prostatic Acid Phosphatase-Pulsed Dendritic Cells (Provenge) In Combination With Bevacizumab In Patients With Serologic Progression Of Prostate Cancer After Definitive Local Therapy
Phase II trial to study the effectiveness of APC8015 combined with bevacizumab in treating patients who have undergone radiation therapy and/or surgery and who have progressive prostate cancer. Biological therapies such as APC8015 use different ways to stimulate the immune system and stop cancer cells from growing. Monoclonal antibodies such as bevacizumab can locate tumor cells and kill them without harming normal cells. Combining monoclonal antibody therapy with biological therapy may kill more cancer cells.
OBJECTIVES:
I. Determine the efficacy of APC8015 (Provenge) and bevacizumab, in terms of decline in
prostate-specific antigen (PSA) value and effect on PSA doubling time, in patients with
progressive prostate cancer.
II. Determine any immune response in patients treated with this regimen. III. Determine the
safety of this regimen in these patients.
OUTLINE:
Autologous dendritic cells (DCs) are harvested and pulsed with prostatic acid
phosphatase-sargramostim fusion protein to produce APC8015 (Provenge). Patients receive
APC8015 IV over 30 minutes and bevacizumab IV over 30-60 minutes on day 1. Treatment repeats
every 14 days for 3 courses. Patients continue to receive bevacizumab alone every 14 days in
the absence of disease progression or unacceptable toxicity.
Patients are followed every month.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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