Vaccine Therapy in Treating Patients With Recurrent Prostate Cancer
Adenocarcinoma of the Prostate, Recurrent Prostate Cancer

About this trial
This is an interventional treatment trial for Adenocarcinoma of the Prostate
Eligibility Criteria
Inclusion Criteria: Histologically confirmed adenocarcinoma of the prostate Must have undergone radical prostatectomy ≥ 3 months ago Prostate-specific antigen (PSA) level ≥ 0.6 ng/mL and rising (after radical prostatectomy) on ≥ 2 measurements separated by ≥ 3 months HLA-A2-positive peripheral blood mononuclear cells by flow cytometry No clinical evidence of local recurrence No palpable induration or mass in prostatic fossa No metastatic prostate cancer No osseous metastases by bone scan Performance status - ECOG 0-1 Performance status - Karnofsky 70-100% More than 1 year WBC ≥ 3,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 AST and ALT ≤ 2.5 times upper limit of normal Bilirubin normal Hepatitis B and C negative Creatinine normal Creatinine clearance ≥ 60 mL/min No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia No history of allergic reactions attributed to compounds of similar chemical or biologic composition to study PSA peptide vaccine or Montanide ISA-51 No history of systemic autoimmune disease or autoimmune disease requiring anti-inflammatory or immunosuppressive therapy Patients with history of autoimmune thyroiditis are eligible provided the patient requires only thyroid hormone replacement therapy AND disease has been stable for ≥ 1 year No known HIV positivity No ongoing or active infection No primary or secondary immune deficiency No psychiatric illness or social situation that would preclude study compliance No history of other uncontrolled illness No prior chemotherapy No prior hormonal therapy No concurrent systemic or ocular steroid therapy, except for any of the following: Inhaled steroids for asthma Limited topical steroids Replacement doses of cortisone More than 4 weeks since prior radiotherapy No prior radiotherapy to the prostate Prior radiotherapy to the pelvis after radical prostatectomy allowed See Disease Characteristics No other concurrent investigational agents No other concurrent anticancer therapy
Sites / Locations
- University of Maryland Greenebaum Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment
Patients receive PSA peptide vaccine (PSA-3A; PSA: 154-163 [155L]) emulsified in Montanide ISA-51 subcutaneously once in weeks 0, 2, 4, 6, 10, 14, and 18 in the absence of disease progression or unacceptable toxicity.