Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Safety and Feasibility Study of Active Immunotherapy in Patients With Metastatic Prostate Carcinoma Using Autologous Dendritic Cells Pulsed With Antigen Encoded in Amplified Autologous Tumor RNA

Conditions
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Prostate Cancer

Intervention / Treatment
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* Biological: therapeutic autologous dendritic cells


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: therapeutic autologous dendritic cells|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the prostate, stage IV prostate cancer