Prostate Cancer Clinical Trial
Official title:
A Randomized, Double Blind, Placebo Controlled Trial of Immunotherapy With Autologous Antigen-Loaded Dendritic Cells (Provenge) for Asymptomatic Metastatic Hormome-Refractory Prostate Cancer
Rationale: Vaccines may make the body build an immune response to kill tumor cells. It is
not yet known if vaccine therapy is effective for prostate cancer.
Purpose: Randomized phase III trial to determine the effectiveness of vaccine therapy in
treating patients who have metastatic prostate cancer that has not responded to hormone
therapy.
Objectives:
I. Compare the time to progression, time to development of disease-related pain, and
incidence of grade 3 or worse treatment-related adverse events in patients with asymptomatic
metastatic hormone refractory adenocarcinoma of the prostate treated with APC8015 versus
control infusion. II. Compare response rate and duration of response in these patients.
Outline: This is a randomized study. Patients are randomized to one of two treatment arms.
Arm I: Autologous dendritic cell precursors (ADCP) are harvested on weeks 0, 2, and 4.
Patients receive APC8015 comprised of ADCP activated with prostatic acid
phosphatase-sargramostim (GM-CSF) fusion protein IV over 30 minutes beginning 2 days after
each harvest for a total of 3 infusions. Arm II: ADCP are harvested as in arm I. Patients
receive unactivated ADCP IV over 30 minutes beginning 2 days after each harvest for a total
of 3 infusions. Pain is assessed weekly for up to 3 years or until 4 weeks after objective
disease progression. Patients are followed monthly for up to 3 years or until disease
progression. At the time of disease progression, patients treated on arm II may receive
treatment on Protocol D9903.
Projected Accrual: A total of 120 patients (80 in arm I and 40 in arm II) will be accrued
for this study.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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