A Randomized Phase II Study of a PSA-Based Vaccine in Patients With Localized Prostate Cancer Receiving Standard Radiotherapy
This trial will evaluate the immunologic effects of a vaccination regimen in HLA-A2 positive
prostate cancer patients. Eligible patients will have localized prostate cancer and be
willing to undergo definitive local radiotherapy. 30 patients will be randomized in a 2:1
ratio into two cohorts (see schema below) with patients in the vaccine arm receiving
vaccination before, during and after primary standard radiotherapy (external beam alone or
in combination with brachytherapy). When enrollment to these two cohorts is complete,
enrollment will begin with up to 19 (9-10 HLA-A2 positive) patients to a third,
non-randomized vaccine cohort. This cohort C will differ from the first vaccine cohort only
in the IL-2 dose and schedule. The vaccine regimen will be composed of (1) a recombinant
vaccinia virus that expresses the Prostate Specific Antigen gene (rV-PSA), admixed with (2)
a recombinant vaccinia virus that expresses B7.1 costimulatory molecule (rV-B7.1); followed
by (3) sequential vaccinations with recombinant fowlpox virus containing the PSA gene
(rF-PSA). All patients on the vaccine arms will, in addition, receive sargramostim and
aldesleukin as part of their vaccination schedule.
The primary endpoint is to identify immunologic response as measured by in vitro analysis of
the patients peripheral blood cells. The immune response of cohorts A and B will be
analyzed at various times to determine whether a specific immune response can be affected by
the vaccination as well as whether radiotherapy has an effect on that immune response. The
serum PSA will be followed as a secondary endpoint.
All patients with PSA-expressing adenocarcinoma of the prostate will be evaluated for
eligibility that includes a history of prior vaccinia (as vaccine against smallpox) and
immunocompetence.
Interventional
Primary Purpose: Treatment
United States: Federal Government
000154
NCT00005916
June 2000
December 2005
Name | Location |
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National Cancer Institute (NCI), 9000 Rockville Pike | Bethesda, Maryland 20892 |