title: Safety profile and anti-tumor effects of adoptive immunotherapy using gamma-delta T cells against advanced renal cell carcinoma: a pilot study.
abstract: OBJECTIVE
  Although various types of immunotherapy have been used to improve the prognosis of patients with advanced renal cell carcinoma (RCC), adoptive immunotherapy using gamma-delta (gammadelta) T cells has not yet been tried. In this study, we designed a pilot study of adoptive immunotherapy using in vitro activated gammadelta T cells against advanced RCC to evaluate the safety profile and possible anti-tumor effects of this study.
  
  
  METHODS
  Patients with advanced RCC after radical nephrectomy were administered via intravenous infusion in vitro-activated autologous gammadelta T cells every week or every 2 weeks, 6-12 times, with 70 JRU of teceleukin. Adverse events, anti-tumor effects and immunomonitoring were assessed. The anti-tumor effects were evaluated according to tumor doubling time (DT) by computed tomography (CT) and immunomonitoring was performed by flow cytometric analysis.
  
  
  RESULTS
  Seven advanced RCC patients were entered in this study. The most common adverse events were fever, general fatigue and elevation of hepatobiliary enzymes, but no severe adverse events were seen. Prolongation of tumor DT was seen in three out of five patients; these three patients showed an increase in the number of gammadelta T cells in peripheral blood and also a high response to the antigen in vitro.
  
  
  CONCLUSIONS
  The results indicated that adoptive immunotherapy using in vitro-activated autologous gammadelta T cells was well tolerated and induced anti-tumor effects.
authors.affiliation: Department of Urology, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan. hirohitokobayashi-jua@umin.ac.jp
authors.forename: Hirohito
authors.initials: H
authors.lastname: Kobayashi
authors.forename: Yoshimasa
authors.initials: Y
authors.lastname: Tanaka
authors.forename: Junji
authors.initials: J
authors.lastname: Yagi
authors.forename: Yukinari
authors.initials: Y
authors.lastname: Osaka
authors.forename: Hayakazu
authors.initials: H
authors.lastname: Nakazawa
authors.forename: Takehiko
authors.initials: T
authors.lastname: Uchiyama
authors.forename: Nagahiro
authors.initials: N
authors.lastname: Minato
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Toma
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002292:Carcinoma, Renal Cell / Q000276:immunology / Q000628:therapy*; D005260:Female; D005434:Flow Cytometry; D006801:Humans; D016219:Immunotherapy, Adoptive / Q000009:adverse effects*; D007680:Kidney Neoplasms / Q000276:immunology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000628:therapy; D009392:Nephrectomy; D010865:Pilot Projects; D016692:Receptors, Antigen, T-Cell, gamma-delta / Q000276:immunology / Q000627:therapeutic use*; D013601:T-Lymphocytes / Q000276:immunology / Q000637:transplantation*; D014182:Transplantation, Autologous
chemical_list: D016692:Receptors, Antigen, T-Cell, gamma-delta