Prostate Cancer Clinical Trial
Official title:
A Phase 1A/1B, Two-Stage Study of a PSA/IL-2/GM-CSF Vaccine for the Treatment of PSA Recurrent Prostate Cancer in Hormone-Naive and Hormone-Independent Patients
This study is investigating the safety and efficacy of a vaccine directed against prostate
tumor cells. The researchers are interested in evaluating the safety and tolerability of the
vaccine, and the effects of the vaccine on survivability, time to measurable disease,
prostate-specific antigen (PSA) level in the blood, and the immune response to the vaccine.
Eligible patients include those with recurrent prostate cancer as shown by elevated levels of
PSA, although there is no evidence of tumors that are measurable by imaging studies. In
addition, to be eligible patients must have prostate cancer that either has not been treated
by hormonal therapy or is not responsive to hormonal therapy.
In Phase 1A, hormone naive and hormone independent patients are enrolled in a 1:1 ratio. All
patients receive intradermal injections of the PSA/IL-2/GM-CSF induction vaccine at Weeks 1,
2, 3, 7, 11 and 15.
In Phase 1B, which will be initiated after Phase 1A, will first receive the induction vaccine
(PSA/IL-2/GM-CSF) according to the same schedule as patients in Phase 1A. Then, in eligible
Phase 1B patients, following the induction vaccine regimen, alternating maintenance
vaccination will be administered as follows: at Weeks 23, 31, and 39, IL-2 alone will be
administered; at Weeks 27, 35, and 43, the complete vaccine (PSA/IL-2/GM-CSF) will be
administered.
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