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A Phase II Randomized, Double Blind,
Controlled Study to Evaluate the Safety and Efficacy of
PROSTVAC- VF� in Combination with
GM-CSF in Patients with Androgen-Independent
Adenocarcinoma of the Prostate
Study Description:
This multi-center, double-blind, randomized, empty vector-controlled trial is
designed to evaluate the safety and efficacy of PROSTVAC-VF
co-administered with GM-CSF versus the empty viral vector co-administered with
placebo in the treatment of patients with androgen-independent prostate cancer (AIPC).
All patients will be required to sign an informed consent prior to the
performance of any on-study procedures. Patients will be screened for
eligibility within 14 days prior to vaccine administration. Patients who meet
all inclusion and exclusion criteria will be centrally randomized into the study
and will receive a unique patient identification number and a blinded treatment
assignment. Randomization will be stratified into treatment groups based on
bisphosphonate use. The ratio of active treatment to empty vector control is 2:1
active:empty vector control.
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