Phase II trial of recombinant alpha-2b interferon in the treatment of metastatic skin melanoma

A pilot study was undertaken to evaluate toxicity and activity of recombinant alpha-2b interferon in patients with metastatic malignant melanoma. Interferon was administered at the dosage of 10 x 10(6) IU/m2, 3 times a week i.m. 21 patients entered the study, 17 pretreated with chemotherapy and/or i...

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Published inOncology Vol. 46; no. 2; p. 96
Main Authors Sertoli, M R, Bernengo, M G, Ardizzoni, A, Brunetti, I, Falcone, A, Vidili, M G, Cusimano, M P, Appino, A, Doveil, G, Fortini, C
Format Journal Article
LanguageEnglish
Published Switzerland 1989
Subjects
Adult
Aged
Drug Evaluation
Female
Humans
Interferon Type I - therapeutic use
Interferon-alpha - administration & dosage
Interferon-alpha - therapeutic use
Male
Melanoma - therapy
Middle Aged
Neoplasm Metastasis
Recombinant Proteins
Skin Neoplasms - therapy
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Summary:A pilot study was undertaken to evaluate toxicity and activity of recombinant alpha-2b interferon in patients with metastatic malignant melanoma. Interferon was administered at the dosage of 10 x 10(6) IU/m2, 3 times a week i.m. 21 patients entered the study, 17 pretreated with chemotherapy and/or immunotherapy and 6 untreated. We obtained 3 partial responses (14.3%; 95% CL, 3.0-36.3%); 9 patients had stable disease. All patients experienced flue-like symptoms and fever; most fatigue and worsening of performance status. Recombinant interferon alpha-2b at the dosage and schedule used has limited but definite activity in metastatic malignant melanoma; the substantial subjective toxicity must be taken into consideration. Further trials testing recombinant alpha interferon in combination with chemotherapeutic agents, like DTIC, are warranted.
ISSN:0030-2414
DOI:10.1159/000226693