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Endpoints were 6\u2010month progression\u2010free survival rate, response rate, and toxicity.<\/jats:p><\/jats:sec><jats:sec><jats:title>METHODS.<\/jats:title><jats:p>Twenty\u2010six patients with Stage IV melanoma, measurable or nonmeasurable disease, performance status of 0\u20132, and adequate renal and hepatic functions were registered. One prior systemic therapy for Stage IV disease was required. Interferon was administered subcutaneously (1 million U) twice daily; thalidomide was orally administered (200\u2013400 mg) each evening in a dose\u2010escalating manner. Response evaluations using Response Evaluation Criteria in Solid Tumors were performed every 8 weeks.<\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS.<\/jats:title><jats:p>After 2 sudden deaths and 1 grade 4 treatment\u2010related pulmonary embolism, this study was temporarily closed. One patient with deep\u2010vein thrombosis and 2 with grade 3 cardiac arrhythmias were reported. The relationship of these events to the treatment was worrisome but not definitive. Grade 3 treatment\u2010related adverse events occurred in 14 of 26 patients. Because of concern for patient safety the study was permanently closed. No treatment responses were seen in the 22 evaluable patients. Estimated 6\u2010month progression\u2010free survival rate was 15% (95% confidence interval [CI], 2%\u201329%), estimated 6\u2010month overall survival was 58% (95% CI, 39%\u201377%), and estimated response probability was 0 of 22 (95% CI, 0%\u201315%).<\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSIONS.<\/jats:title><jats:p>This regimen demonstrated a lack of response and was associated with multiple severe toxicities. Further investigation of interferon alpha\u20102b and thalidomide in this dose and schedule is not warranted. 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