Vaccine Therapy in Treating Patients With Recurrent Prostate Cancer

PRIMARY OBJECTIVES:

I. Determine the T-lymphocyte immune response in patients with recurrent adenocarcinoma of the prostate treated with prostate-specific antigen (PSA) peptide vaccine (PSA-3A; PSA: 154-163 [155L]) emulsified in Montanide ISA-51.

SECONDARY OBJECTIVES:

I. Determine the toxicity of this vaccine in these patients. II. Determine the effect of this vaccine on serum PSA level in these patients.

OUTLINE: This is a pilot study.

Patients receive prostate-specific antigen (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.

NOTE: *A rise in PSA alone is not considered disease progression.

After completion of study treatment, patients are followed at 1 and 4 weeks.

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