Conventional dose melphalan is inactive in metastatic melanoma: results ofan Eastern Cooperative Oncology Group Study (E1687)

Despite reports that i.v. melphalan is active in the settings of conditioni ng regimens utilizing high-dose chemotherapy for autologous bone marrow tra nsplantation and in isolated limb perfusion for the treatment of malignant melanoma, its activity at conventional doses has never been defined in this disease. We conducted a phase II study of conventional-dose i.v. melphalan (30 mg/m(2)) in 17 patients with metastatic melanoma. All patients were pr eviously untreated with chemotherapy with performance status 0, 1 or 2. For ty seven cycles were given with a median of two cycles. One patient was not evaluable due to early death. There were no responses in the 16 patients, resulting in a 0% response rate (95% confidence interval = 0-17%). We concl ude that conventional-dose melphalan by i.v. administration has no apprecia ble activity in patients with metastatic malignant melanoma. [(C) 1999 Lipp incott Williams & Wilkins.].