title: Dendritic cell vaccine for recurrent high-grade gliomas in pediatric and adult subjects: clinical trial protocol.
abstract: BACKGROUND
  Although there have been significant advances in understanding the basic pathogenesis of glioblastoma multiforme, the median survival of patients has changed little in the past 25 years. Recent studies have suggested that immune modulation through dendritic cell (DC) vaccines may stimulate the immune system against tumor antigens and potentially increase survival.
  
  
  OBJECTIVE
  To determine whether the use of adjuvant vaccination with autologous DCs (matured in situ after being loaded with tumor cell lysate derived from autologous refractory gliomas) is safe, feasible, and beneficial for adult and pediatric patients with recurrent high-grade gliomas.
  
  
  METHODS
  The study design is a single-center, nonrandomized, open phase I clinical trial. A total of 20 patients with malignant gliomas will be enrolled preoperatively over 2 years. Patients will be given adjuvant vaccination with autologous DCs loaded with tumor lysate after maximal safe surgical resection.
  
  
  OBJECTIVE
  Using topical imiquimod before vaccination, it is anticipated that the immune response in vaccinated patients and potentially Overall survival will be greater than that demonstrated in the literature. We anticipate that there will be minimal side effects (minor dermatitis) associated with this treatment.
  
  
  CONCLUSIONS
  In the current trial, we assess immune response, safety, and survival using a novel vaccine protocol developed in Belgium that seems to markedly increase survival of certain subjects. Nevertheless, larger randomized clinical studies need to be performed to evaluate fully the efficacy of this therapy for both recurrent and newly diagnosed glioblastoma.
authors.affiliation: Departments of *Neurological Surgery, ‡Neurology, and §Pediatrics, University of Miami Miller School of Medicine, Miami, Florida.
authors.forename: Ashish H
authors.initials: AH
authors.lastname: Shah
authors.forename: Amade
authors.initials: A
authors.lastname: Bregy
authors.forename: Deborah O
authors.initials: DO
authors.lastname: Heros
authors.forename: Ricardo J
authors.initials: RJ
authors.lastname: Komotar
authors.forename: John
authors.initials: J
authors.lastname: Goldberg
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001932:Brain Neoplasms / Q000276:immunology / Q000628:therapy*; D019496:Cancer Vaccines / Q000627:therapeutic use*; D015331:Cohort Studies; D003713:Dendritic Cells / Q000502:physiology*; D005260:Female; D005910:Glioma / Q000276:immunology / Q000628:therapy*; D006801:Humans; D007167:Immunotherapy; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D055815:Young Adult; D017321:Clinical Trials, Phase I as Topic
chemical_list: D019496:Cancer Vaccines