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.

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