A phase II study of interferon-α2b with dacarbazine, carmustine, cisplatin and tamoxifen in metastatic melanoma

A phase II trial was conducted to determine the efficacy and toxicity of the addition of interferon-α2b (IFN-α) to the chemotherapy combination of dacarbazine (DTIC), carmustine (BCNU), cisplatin and tamoxifen (DBCT), in patients with stage III or IV melanoma. Treatment consisted of DTIC 220 mg/m² and cisplatin 25 mg/m² intravenously on days 1-3, BCNU 100 mg/m² IV on day 1 only, tamoxifen 20 mg orally twice daily and IFN-α 5 x 10⁶ units/m² subcutaneously on days 1-5. Cycles were repeated every 4 weeks. All patients received a loading dose of tamoxifen 100 mg orally twice daily for 5 days before the first course of therapy. Of the 24 patients treated, three (13%) achieved a complete response (CR) and six (25%) a partial response (PR), for an overall response rate of 38% (95% confidence interval, 1758%). Two patients, one who achieved a clinical CR and one a PR, had pathologically confirmed complete responses. Severe myelosuppression occurred in 47% of cycles and constitutional symptoms were common. Overall, the addition of IFN- α to the DBCT regimen did not appear to enhance the response rate and may have increased toxicity.