Fourteen patients with metastatic malignant melanoma that had failed to respond to standard dacarbazine-based chemotherapy treatment were entered into a phase II study of pegylated liposomal doxorubicin (Caelyx) given as a single intravenous injection at a dose of 50 mg/m(2) at 28 day intervals. No objective responses were documented. Treatment was well tolerated. We conclude that pegylated liposomal doxorubicin does not demonstrate sufficient activity in metastatic melanoma to warrant further investigation in this setting.