Interferon alpha-2b and thalidomide in previously treated patients with disseminated malignant melanoma: SWOG 0026

7527 Background: SWOG 0026 was a phase II evaluation of antiangiogenesis therapy using interferon alpha-2b, given in an antiangiogenetic schedule, with thalidomide in patients with disseminated melanoma. The six-month progression-free survival (PFS) rate, response rate, and evaluation of toxicities were goals. Methods: 26 of 35 planned patients with Stage IV melanoma were registered. Patients had measurable or non-measurable disease, a performance status of 0–2, and adequate renal and hepatic function. One prior systemic therapy for Stage IV disease was required. Interferon 1 MU subcutaneously bid and thalidomide in an escalating manner consisting of 200 mg days 1–7, 300 mg days 8–14 and 400 mg days 15-study completion was administered each evening. Response evaluations using RECIST criteria were performed every 12 weeks. Results: After two sudden deaths, and one patient with grade 4 pulmonary embolism, this study was temporarily closed (9/10/02). An additional patient with deep vein thrombosis and 2 pati...