vaccine therapy in treating patients with metastatic prostate cancer

Conditions: Prostate Cancer

Summary: rationale: vaccines made from a person's cancer cells may make the body build an immune response to kill prostate tumor cells. purpose: phase i trial to study the effectiveness of vaccine therapy in treating patients who have metastatic prostate cancer.

objectives: * determine the safety and feasibility of autologous dendritic cells transfected with autologous total tumor rna in patients with metastatic prostate cancer. * determine the presence, frequency, and activation status of tumor specific and prostate specific antigen (psa) specific cellular immune responses in patients treated with this regimen. * determine delayed-type hypersensitivity reactions to psa protein and other recall antigens in patients before and after being treated with this regimen. * determine clinical responses based on clinical and biochemical (psa) response criteria in patients treated with this regimen. * determine a platform for immunological treatment using dendritic-cell based tumor vaccines in these patients. outline: this is a dose escalation study. tumor tissue and peripheral blood stem cells are collected from patients and cultured in vitro with sargramostim (gm-csf) and interleukin-4 for 7 days to produce dendritic cells (dc). patients receive autologous dc transfected with autologous prostate carcinoma rna intradermally once weekly on weeks 0-3 for a total of 4 doses. cohorts of 3-6 patients receive escalating doses of dc until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. patients are followed at weeks 6, 8, 10, and 12; every 3 months for 9 months; and then annually for 2 years. projected accrual: a total of 18 patients will be accrued for this study within 20 months.

Eligibility criteria:
disease characteristics: * histologically confirmed metastatic adenocarcinoma of the prostate * stage d1-3 * regional lymph node, bone, visceral, or soft tissue metastases * no transitional cell or small cell carcinoma * testosterone less than 50 mg/l if prior treatment with luteinizing hormone releasing hormone (lhrh) analogues or estrogens * evidence of androgen refractory disease after surgical castration and discontinuation of lhrh analogue therapy * no previously irradiated or new cns metastases patient characteristics: age: * 18 and over performance status: * karnofsky 70-100% life expectancy: * more than 6 months hematopoietic: * wbc at least 3,000/mm\^3 * hemoglobin at least 9 g/dl * platelet count at least 100,000/mm\^3 hepatic: * bilirubin less than 2.0 mg/dl * pt at least 11.3 seconds but no greater than 13.3 seconds * ptt at least 20.1 seconds but no greater than 32.9 seconds * no hepatic disease * no viral hepatitis renal: * creatinine less than 2.5 mg/dl cardiovascular: * no new york heart association class iii or iv heart disease pulmonary: * no asthma * no chronic obstructive pulmonary disease * no severe lung disease other: * no other medical illness or psychological impediment that would preclude study * no other concurrent malignancy except nonmelanoma skin cancer or controlled superficial bladder cancer * no active acute or chronic infection including symptomatic urinary tract infection * no autoimmune disease (e.g., inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, scleroderma, or multiple sclerosis) * hiv negative * adequate peripheral vein access prior concurrent therapy: biologic therapy: * prior biologic therapy allowed * no other concurrent immunotherapy chemotherapy: * prior chemotherapy allowed * no concurrent chemotherapy endocrine therapy: * see disease characteristics * at least 4 weeks since prior non-steroidal hormonal therapy if increase in psa while receiving non-steroidal hormonal therapy * at least 6 weeks since prior steroids * concurrent lhrh analogues for gonadal androgen suppression allowed * no concurrent steroid therapy * no concurrent corticosteroids radiotherapy: * see disease characteristics * prior palliative radiotherapy for bone metastases allowed * prior prostatic radiotherapy allowed * at least 4 weeks since prior radiotherapy * at least 12 weeks since prior strontium chloride sr 89 * no concurrent radiotherapy surgery: * see disease characteristics other: * recovered from prior therapy * no concurrent immunosuppressive agents (e.g., azathioprine or cyclosporine)

Keywords: adenocarcinoma of the prostate stage iv prostate cancer