A Phase I/II Study of Autologous Dendritic Cells Pulsed With Apoptotic Tumor Cells (DC/LNCaP) Administered Subcutaneously to Prostate Cancer Patients.
This is a Phase I/II dendritic cell vaccine study for patients with prostate cancer. Our
laboratory has demonstrated that effective tumor immunity in humans is associated with, and
likely mediated at least in part by tumor antigen-specific killer T cells (Albert et al.,
1998a; Darnell, 1999; Darnell and Posner, 2003). Moreover, we have demonstrated that
apoptotic material derived from dying tumor cells are a potent means of delivering antigen
to DCs and subsequently triggering tumor antigen-specific T cell responses ex vivo (Albert
et al., 1998a; Albert et al., 1998c). In this study, patients with 3 consecutive rises in
PSA measured at least 2 week apart, after definite local therapy (prostatectomy or
radiation) will be recruited. Peripheral blood monocytes will be collected by leukapheresis
and dendritic cells will be generated in the Cleanroom in the Laboratory of Molecular
Neuro-Oncology. These dendritic cells will be pulsed with apoptotic prostate cancer cells
from a cell line (LNCaP), harvested, tested for certain release criteria, and then injected
as vaccine. When patients are found to be eligible for the study, they will be randomized
into either the experimental group or the placebo group for the purposes of comparing
adverse events between groups only. Vaccine plus 3 boosters (or placebo) will be given,
each two weeks apart. After the third booster, patients will be unblinded. Those receiving
the vaccine will when enter the follow up phase which includes a post treatment
leukapheresis. Those in the placebo group will cross over and receive the vaccine and
boosters. The primary outcomes to be evaluated are toxicity and activity. Patients will be
evaluated for both local and systemic toxicity. For activity, we measure both immunological
and clinical responses to the vaccine, comparing measures taken before and after
vaccination, combining patients in both arms.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Adverse Event
Occurrence of adverse events (AE) was compared between the placebo and vaccine groups during the blinded phase (the 1st 9 weeks). At the end of this phase, all were unblinded, and those who received placebo crossed over to now receive vaccine. All serious AEs and any other AEs that occurred 5 times or more are reported. The exact binomial test was used to compare the occurrence of each AE between groups.
End of blinded phase (wk 9)
Yes
Robert B. Darnell, MD, PHD
Principal Investigator
Rockefeller University
United States: Food and Drug Administration
RDA 0466
NCT00289341
March 2002
November 2008
Name | Location |
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Rockefeller University Hospital | New York, New York 10021-6399 |