[Recombinant human tumor necrosis factor alpha (TNF): preclinical studies and results of early clinical trials].

The direct cytostatic and cytotoxic effect of recombinant human TNF alpha on human tumor xenografts encourages further clinical investigation. The most commonly observed toxicities (even after low doses), include constitutional symptoms, such as fever, chills, headache, hypotension and local inflammatory reaction at the injection point. Pharmacokinetic study has shown a rapid clearance following iv. infusion (half time 10-30 min). The phase I study has not revealed any beneficial effect so far (2-4% response), which may be due to low doses. Now the phase II investigations has started incorporating the combined application of TNF with other cytokines and cytostatics as well. The preliminary results seem to be promising.