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Results of a phase 1 study utilizing monocyte-derived dendritic cells pulsed with tumor RNA in children and young adults with brain cancer

Departments of Hematology and Oncology (D.A.C, L.M.O., A.M.N., F.J.R., G.M.A., P.D., D.M.A.), Neurosurgery (W.M.), and Immunology (M.L.K.T.), The Royal Children's Hospital, Parkville, Victoria, 3051; Department of Hematology and Oncology, The Royal Children's Hospital, Brisbane, Queensland, 4029 (T.E.H.); Department of Pediatrics (D.A.C., D.M.A.), The University of Melbourne, Parkville, Victoria, 3052; The Murdoch Childrens Research Institute (D.A.C., A.M.N., G.M.A., T.E.H., M.L.K.T., D.M.A.), Parkville, Victoria, 3052; Australia

³ Address correspondence to David M. Ashley, Department of Hematology and Oncology, Royal Children's Hospital, Flemington Road, Parkville, Victoria, Australia 3052 (david.ashley{at}rch.org.au).

Abstract

We conducted a phase 1 study of 9 pediatric patients with recurrent brain tumors using monocyte-derived dendritic cells pulsed with tumor RNA to produce antitumor vaccine (DC_RNA) preparations. The objectives of this study included (1) establishing safety and feasibility and (2) measuring changes in general, antigen-specific, and tumor-specific immune responses after DC_RNA. Dendritic cells were derived from freshly isolated monocytes after 7 days of culture with IL-4 and granulocyte-macrophage colony-stimulating factor, pulsed with autologous tumor RNA, and then cryopreserved. Patients received at least 3 vaccines, each consisting of an intravenous and an intradermal administration at biweekly intervals. The study showed that this method for producing and administering DC_RNA from a single leukapheresis product was both feasible and safe in this pediatric brain tumor population. Immune function at the time of enrollment into the study was impaired in all patients tested. While humoral responses to recall antigens (diphtheria and tetanus) were intact in all patients, cellular responses to mitogen and recall antigens were below normal. Following DC_RNA vaccine, 2 of 7 patients showed stable clinical disease and 1 of 7 showed a partial response. Two of 7 patients who were tested showed a tumor-specific immune response to DC_RNA. This study showed that DC_RNA vaccines are both safe and feasible in children with tumors of the central nervous system with a single leukapheresis.

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