title: Systemic adoptive T-cell immunotherapy in recurrent and metastatic carcinoma of the head and neck: a phase 1 study.
abstract: OBJECTIVE
  To evaluate the feasibility and toxic effects of systemic adoptive T-cell immunotherapy in patients with unresectable squamous cell carcinoma of the head and neck (SCCHN).
  
  
  METHODS
  Nonrandomized phase 1 clinical trial.
  
  
  METHODS
  Academic tertiary care hospital.
  
  
  METHODS
  Between April 1, 1996, and September 30, 1998, 17 patients with confirmed recurrent and metastatic SCC of the upper aerodigestive tract were enrolled. Two patients did not receive T cells because of poor vaccine response. Fifteen patients were successfully treated with T-cell immunotherapy.
  
  
  METHODS
  Patients were vaccinated on the thigh with irradiated autologous tumor cells admixed with granulocyte-macrophage colony-stimulating factor (GM-CSF) followed by 3 additional daily injections of GM-CSF at the vaccination site. Eight to 10 days later, tumor cell vaccine-draining inguinal lymph nodes were resected, and lymph node lymphocytes were activated with staphylococcal enterotoxin A and expanded in interleukin 2 in vitro. Resulting cultured cells were infused into patients peripherally on an outpatient basis.
  
  
  RESULTS
  Toxic effects of infusion were limited to grade 2 reactions in 3 of 16 treatments. One patient required overnight hospitalization for fever and emesis. Median cell expansion was 37 times (range, 4-416 times), and median cell dose was 7.5 x 10(9) (range, 1.3 x 10(8) to 4.2 x 10(10)). Infused cells were predominantly CD3+ (>97%), being a mixture of CD4+ and CD8+ cells. Three patients demonstrated stabilization of previously progressive disease. Two patients experienced favorable clinical courses after adoptive T-cell transfer, including 1 patient with no evidence of disease 4 years after surgical resection of a vertebral body metastasis.
  
  
  CONCLUSIONS
  Adoptive immunotherapy is a technically feasible and safe treatment with low toxicity and may demonstrate therapeutic activity in patients with unresectable SCCHN.
authors.affiliation: Department of Otalaryngology and Communicative Disorders, Cleveland Clinic Foundation, Cleveland, OH, USA. wyattto@pol.net
authors.forename: W C
authors.initials: WC
authors.lastname: To
authors.forename: B G
authors.initials: BG
authors.lastname: Wood
authors.forename: J C
authors.initials: JC
authors.lastname: Krauss
authors.forename: M
authors.initials: M
authors.lastname: Strome
authors.forename: R M
authors.initials: RM
authors.lastname: Esclamado
authors.forename: P
authors.initials: P
authors.lastname: Lavertu
authors.forename: D
authors.initials: D
authors.lastname: Dasko
authors.forename: J A
authors.initials: JA
authors.lastname: Kim
authors.forename: G E
authors.initials: GE
authors.lastname: Plautz
authors.forename: B E
authors.initials: BE
authors.lastname: Leff
authors.forename: V
authors.initials: V
authors.lastname: Smith
authors.forename: K
authors.initials: K
authors.lastname: Sandstrom-Wakeling
authors.forename: S
authors.initials: S
authors.lastname: Shu
mesh_terms: D000328:Adult; D000368:Aged; D002294:Carcinoma, Squamous Cell / Q000628:therapy*; D005260:Female; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000008:administration & dosage; D006258:Head and Neck Neoplasms / Q000628:therapy*; D006801:Humans; D016219:Immunotherapy, Adoptive / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local; D013601:T-Lymphocytes / Q000276:immunology*; D016896:Treatment Outcome
chemical_list: D016178:Granulocyte-Macrophage Colony-Stimulating Factor