Report of a clinical trial in 12 patients with head and neck cancer treated intratumorally and peritumorally with Multikine

Raphael Feinmesser*, Britta Hardy, Rima Sadov, Ariel Shwartz, Paul Chretien, Meora Feinmesser

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review


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. Conclusion: Multikine warrants further investigation for inclusion in the pharmacotherapeutic armamentarium of head and neck cancer.

Original languageEnglish
Pages (from-to)874-881
Number of pages8
JournalArchives of Otolaryngology - Head and Neck Surgery
Issue number8
StatePublished - 1 Aug 2003


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