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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
In Stage 1 (Phase 1A), patients receive intradermal injections of PSA/IL-2/GM-CSF vaccine at Weeks 1, 2, 3, 7, 11, and 15. In Stage 2 (Phase 1B), patients will receive the same course of vaccine (induction as in Phase 1A; this will be followed in eligible patients by maintenance vaccinations alternating between IL-2 alone at Weeks 23, 31, and 39) and complete vaccine (PSA/IL-2/GM-CSF) at Weeks 27, 35, and 43.
VA San Diego Healthcare System
San Diego, California, United States
Dose Limiting Adverse Events
Time frame: From first injection until 30 days past the last injection
PSA Doubling Time (PSADT) and PAP levels
Time frame: Measured at pretreatment screening, prior to first vaccine injection, and then following vaccination at treatment Weeks 7, 15, 19 (Phase 1A), and then every 12 weeks up to Week 103 (Phase 1B).
Time to measurable disease
Time frame: Time to confirmation of disease recurrence. Patients undergo bone scans and CT scans of chest, abdomen, and pelvis at pretreatment and then at Week 19, and every 24 weeks (6 months) until Week 105.
Time to subsequent therapy
Time frame: Time (days) from Day 1 (first day of vaccine treatment) to either the next investigational anticancer treatment or the first supplemental palliative treatment, up to Week 105.
Overall survival
Time frame: Time (days) from Day 1 to the patient's death. Patients will be followed up to Week 105.
Vaccine-induced immune response including antiPSA antibodies, lymphocyte activation assays, and serum and intracellular cytokine levels
Time frame: Measured at pretreatment screening or Day 1 pre-vaccination, and then treatment Weeks 7 and 19, and then every 12 weeks up to Week 103
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