Spots Global Cancer Trial Database for Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer

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Trial Identification

Brief Title: Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer

Official Title: 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

Study ID: NCT00010127

Conditions

Prostate Cancer

Interventions

therapeutic autologous dendritic cells

Study Description

Brief 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.

Detailed Description: 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.