A Phase I Trial of Continuous Infusion UCN-01 in Patients With Refractory Neoplasms

Summary

This is a dosage escalation study to estimate the maximum tolerated dose of staurosporine analogue UCN-01. Groups of 3 to 6 patients receive a 72-hours intravenous continuous infusions of UCN-01 from day 1 to day 4 of each cycle the first cycle only, and over 36-hours on subsequent cycles. The side effects are allowed to disappear for up to 28 days. This cycle is repeated after evaluations and follow-ups, which are every 4 weeks, as long as the patient benefits.

Timeline

Start

1995-08

Primary completion

—

Completion

2002-05

Publications

• Background Seynaeve CM, Kazanietz MG, Blumberg PM, Sausville EA, Worland PJ. Differential inhibition of protein kinase C isozymes by UCN-01, a staurosporine analogue. Mol Pharmacol. 1994 Jun;45(6):1207-14.
• Background Seynaeve CM, Stetler-Stevenson M, Sebers S, Kaur G, Sausville EA, Worland PJ. Cell cycle arrest and growth inhibition by the protein kinase antagonist UCN-01 in human breast carcinoma cells. Cancer Res. 1993 May 1;53(9):2081-6.
• Background Akinaga S, Gomi K, Morimoto M, Tamaoki T, Okabe M. Antitumor activity of UCN-01, a selective inhibitor of protein kinase C, in murine and human tumor models. Cancer Res. 1991 Sep 15;51(18):4888-92.

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