title: Report of a clinical trial in 12 patients with head and neck cancer treated intratumorally and peritumorally with multikine.
abstract: BACKGROUND
  There is cumulative evidence suggesting that cells of the immune system recognize and may participate in eradicating neoplastic cells. As a result, immune modulation, first with interleukin 2 and later with other cytokines, has been tried in the clinical setting as part of antitumor therapy.
  
  
  OBJECTIVE
  To examine the effectiveness and toxicity of a combination of natural interleukins in patients with squamous cell head and neck cancer.
  
  
  METHODS
  Twelve previously untreated patients with various head and neck cancers were treated by peritumoral injection of a combination of cytokines (Multikine), in addition to zinc sulfate, indomethacin, and a single dose of cyclophosphamide, which were administered systemically. Response was evaluated clinically and histopathologically. T-lymphocyte determinants were studied by fluorescence-activated cell sorter analysis (against controls).
  
  
  RESULTS
  Two patients showed complete regression and another 2 showed partial regression. There were no serious adverse effects of treatment. Pathological study results showed tumor fragmentation and the appearance of multinucleated macrophages. Fluorescence-activated cell sorter analysis showed lymphocyte activation, reflected by an unusually high number of cytotoxic T-lymphocyte activation 4 cells and natural killer cells.
  
  
  CONCLUSIONS
  Multikine warrants further investigation for inclusion in the pharmacotherapeutic armamentarium of head and neck cancer.
authors.affiliation: Department of Otolaryngology and Head and Neck Surgery, Rabin Medical Center, Petah Tiqwa, Israel. feinmesserr@clalit.org.il
authors.forename: Raphael
authors.initials: R
authors.lastname: Feinmesser
authors.forename: Britta
authors.initials: B
authors.lastname: Hardy
authors.forename: Rima
authors.initials: R
authors.lastname: Sadov
authors.forename: Ariel
authors.initials: A
authors.lastname: Shwartz
authors.forename: Paul
authors.initials: P
authors.lastname: Chretien
authors.forename: Meora
authors.initials: M
authors.lastname: Feinmesser
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000276:immunology / Q000473:pathology; D003520:Cyclophosphamide / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005260:Female; D005434:Flow Cytometry; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000276:immunology / Q000473:pathology; D006801:Humans; D007213:Indomethacin / Q000627:therapeutic use; D015552:Injections, Intralesional; D007378:Interleukins / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D019287:Zinc Sulfate / Q000627:therapeutic use
chemical_list: D007378:Interleukins; D019287:Zinc Sulfate; D003520:Cyclophosphamide; D007213:Indomethacin