Phase II study of interferon α-2a and dacarbazine in advanced melanoma

E. Bajetta, E. Negretti, B. Giannotti, L. Brogelli, I. Brunetti, M. R. Sertoli, M. G. Bernengo, M. C. Sofra, G. Maifredi, G. Zumiani, G. Comella, R. Buzzoni, A. Di Leo, D. Criscuolo, G. Massimini, N. Cascinelli

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Based on the report of some activity of combination therapy with dacarbazine (DTIC) and interferon α-2a (rIFN α-2a) in disseminated melanoma, we conducted a phase II study to determine the feasibility and efficacy in a large series of patients. DTIC was administered in 79 patients at the dose of 800 mg/m2 every 3 weeks and rIFN α-2a was given daily at the dose of 9 x 106 IU for the first 10 weeks and three times a week thereafter. Among the 75 evaluable patients, 25% achieved an objective response, with 8% complete and 17% partial remissions. The regression occurred within a mean time of 1.9 ± 1.03 months from starting therapy and the mean duration of response was 8.2 ± 4.2 months. The major side effects were vomiting, anorexia, fever, fatigue, and myalgia. There was one death related to sepsis after myelosuppression. In the other patients bone marrow and liver toxicities were not remarkable. Our data reveal that a combination regimen of rIFN α-2a with a cytotoxic agent has some therapeutic activity in the management of advanced malignant melanoma.

Original languageEnglish
Pages (from-to)405-409
Number of pages5
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Issue number5
Publication statusPublished - 1990

ASJC Scopus subject areas

  • Cancer Research
  • Oncology


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