Local injection of OK-432/fibrinogen gel into head and neck carcinomas.

Immunotherapy with biological response modifiers (BRM) is a possible strategy against head and neck solid tumours. However, the rapid disappearance of BRM from the tumour area is one of the reasons for its limited clinical application. In this pilot study, fibrinogen gel containing OK-432 (a compound composed of attenuated Streptococcus pyogenes), an inducer of natural killer cells and T-cell cytotoxity, was injected directly into head and neck solid tumours of 15 patients. A dose of 5 Klinische Einheiten (KE) of OK-432 was reconstituted in 1 ml aprotinin and mixed with fibrinogen, the latter to maintain the OK-432 locally. 3 patients showed tumour regression, and in addition, we observed histological changes in the injected tumour of all patients. These results suggest that OK-432/fibrinogen gel generates a local immune response, leading to tumour regression.