Background: Treosulfan is a bifunctional alkylating cytostatic agent that h
as mainly been used in the therapy of advanced ovarian cancer. Lately a gro
wth inhibiting effect could be detected in human renal cell carcinoma-cell
lines as well. In vitro, Treosulfan showed an even higher growth inhibition
than Vinblastine. Materials and methods: We performed a small clinical pha
se II study using Treosulfan as a monotherapy in the treatment of metastati
c renal cell carcinoma. Treosulfan was given to 15 patients with bidimensio
nally measurable metastases. Results: 10 patients were evaluable. Side effe
cts were negligeable. A complete or even partial remission was not seen. 4
patients showed no change, whereas 6 were progressive. The aver age time to
progress was short (4months, range 1 to 12 months). Conclusions: Since Tre
osulfan did not lead to a measurable tumor remission in the given dose regi
men it does not seem to be suitable for the therapy of metastatic renal cel
l carcinoma.