title: A phase I/II clinical trial investigating the adverse and therapeutic effects of a postoperative autologous dendritic cell tumor vaccine in patients with malignant glioma.
abstract: Previous clinical trials of dendritic cell (DC)-based immunotherapy in patients with glioblastoma multiforme (GBM) have reported induction of systemic immune responses and prolonged survival. From 2003 to 2005, we performed a clinical trial in which patients with malignant glioma underwent surgery for maximal cytoreduction followed by a 6-month 10-injection course of autologous DC-tumor vaccine therapy, each injection containing 1-6×10(7) DC. Of the 17 treated patients (16 with World Health Organization grade IV and one with grade III glioma), eight (47.1%) had an initial transient elevation in aspartate aminotransferase (AST)/alanine aminotransferase (ALT). Vaccination caused some tumor shrinkage and increased concentration of tumor-infiltrating CD8(+) lymphocytes. Median survival and 5-year survival were 525 days and 18.8%, respectively, for 16 patients with grade IV glioma (381 days and 12.5% for eight newly diagnosed; 966 days and 25% for eight relapsed patients) compared to 380 days and 0% for 63 historical control patients. We concluded that autologous DC-tumor immunotherapy benefits patients with malignant glioma but may cause transient but reversible elevation of serum AST/ALT levels.
authors.affiliation: Department of Neurosurgery, Chang Gung Memorial Hospital, Taoyuan, Taiwan.
authors.forename: Chen-Nen
authors.initials: CN
authors.lastname: Chang
authors.forename: Yin-Cheng
authors.initials: YC
authors.lastname: Huang
authors.forename: Den-Mei
authors.initials: DM
authors.lastname: Yang
authors.forename: Kenichiro
authors.initials: K
authors.lastname: Kikuta
authors.forename: Kuo-Jen
authors.initials: KJ
authors.lastname: Wei
authors.forename: Toshihiko
authors.initials: T
authors.lastname: Kubota
authors.forename: Wen-Kuang
authors.initials: WK
authors.lastname: Yang
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D015703:Antigens, CD / Q000378:metabolism; D001932:Brain Neoplasms / Q000276:immunology / Q000401:mortality / Q000628:therapy*; D019496:Cancer Vaccines; D003713:Dendritic Cells / Q000276:immunology*; D005260:Female; D005500:Follow-Up Studies; D005904:Glial Fibrillary Acidic Protein / Q000378:metabolism; D005910:Glioma / Q000276:immunology / Q000401:mortality / Q000628:therapy*; D006801:Humans; D016219:Immunotherapy, Adoptive / Q000009:adverse effects / Q000379:methods*; D053208:Kaplan-Meier Estimate; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D011184:Postoperative Period; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D015703:Antigens, CD; D019496:Cancer Vaccines; D005904:Glial Fibrillary Acidic Protein