Report of a clinical trial in 12 patients with head and neck cancer treated intratumorally and peritumorally with multikine.
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.
Feinmesser
Raphael
R
Department of Otolaryngology and Head and Neck Surgery, Rabin Medical Center, Petah Tiqwa, Israel. feinmesserr@clalit.org.il
Hardy
Britta
B
Sadov
Rima
R
Shwartz
Ariel
A
Chretien
Paul
P
Feinmesser
Meora
M
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
D007378:Interleukins; D019287:Zinc Sulfate; D003520:Cyclophosphamide; D007213:Indomethacin