vaccine therapy plus interleukin-12 in treating patients with metastatic prostate cancer that has not responded to hormone therapy

Conditions: Prostate Cancer

Summary: rationale: vaccines made from a patient's white blood cells may make the body build an immune response to kill cancer cells. interleukin-12 may kill cancer cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells. combining vaccine therapy with interleukin-12 may kill more tumor cells. purpose: phase ii trial to study the effectiveness of vaccine therapy combined with interleukin-12 in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

objectives: * determine whether immunization with prostate-specific membrane antigen-pulsed autologous peripheral blood mononuclear cells and interleukin-12 can promote specific t-cell priming in patients with metastatic hormone-refractory prostate cancer. * determine the clinical response in patients treated with this regimen. outline: patients receive prostate-specific membrane antigen-pulsed autologous peripheral blood mononuclear cells subcutaneously (sc) on day 1 and interleukin-12 sc on days 1, 3, and 5. treatment repeats every 21 days for 3-9 courses in the absence of disease progression or unacceptable toxicity. patients are followed every 3 months. projected accrual: a total of 12-37 patients will be accrued for this study within 37 weeks.

Eligibility criteria:
disease characteristics: * histologically confirmed metastatic adenocarcinoma of the prostate * hla-a2 positive * progressive measurable systemic disease * psa at least 5 ng/ml with 2 consecutive rising psa levels at least 1 week apart and no measurable disease or * objective evidence of disease progression by a 20% increase in the sum of longest diameter of all target lesions or evidence of new lesions by ct or bone scan regardless of psa status * lesions must be at least 1 cm to be considered measurable * progressive systemic disease after discontinuation of anti-androgen therapy * previously treated with orchiectomy (testosterone less than 50 ng/ml) or luteinizing hormone-releasing hormone (lhrh) analogue therapy with or without anti-androgens * if on lhrh analogue therapy, must continue therapy during study * brain metastases allowed if previously treated, clinically stable, and weaned from prior corticosteroids patient characteristics: age: * over 18 performance status: * karnofsky 70-100% life expectancy: * at least 12 weeks hematopoietic: * absolute neutrophil count greater than 1,500/mm\^3 * hemoglobin greater than 9 g/dl * platelet count greater than 100,000/mm\^3 * no active gastrointestinal bleeding hepatic: * bilirubin less than 1.5 times upper limit of normal (uln) * sgpt normal * hepatitis b surface antigen negative renal: * creatinine less than 1.5 times uln * calcium less than 11 mg/dl cardiovascular: * no significant cardiovascular disease * no cardiac arrhythmia requiring therapy other: * fertile patients must use effective barrier contraception * no intrinsic immunosuppression * hiv negative * no serious concurrent infection * no psychiatric illness that would preclude study compliance * no clinically significant autoimmune disease * no uncontrolled peptic ulcer disease * no history of inflammatory bowel disease prior concurrent therapy: biologic therapy: * at least 4 weeks since prior biologic therapy chemotherapy: * not specified endocrine therapy: * see disease characteristics * at least 4 weeks since prior flutamide * at least 6 weeks since prior bicalutamide or nilutamide * no concurrent systemic corticosteroids except physiologic replacement doses radiotherapy: * not specified surgery: * see disease characteristics other: * no concurrent immunosuppressive drugs (e.g., cyclosporine)

Keywords: adenocarcinoma of the prostate stage iv prostate cancer recurrent prostate cancer