title: Phase II trial of recombinant alpha-2b interferon in the treatment of metastatic skin melanoma.
abstract: 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.
authors.affiliation: Istituto Nazionale per la Ricerca sul Cancro, Servizio di Oncologia Medica, Genova.
authors.forename: M R
authors.initials: MR
authors.lastname: Sertoli
authors.forename: M G
authors.initials: MG
authors.lastname: Bernengo
authors.forename: A
authors.initials: A
authors.lastname: Ardizzoni
authors.forename: I
authors.initials: I
authors.lastname: Brunetti
authors.forename: A
authors.initials: A
authors.lastname: Falcone
authors.forename: M G
authors.initials: MG
authors.lastname: Vidili
authors.forename: M P
authors.initials: MP
authors.lastname: Cusimano
authors.forename: A
authors.initials: A
authors.lastname: Appino
authors.forename: G
authors.initials: G
authors.lastname: Doveil
authors.forename: C
authors.initials: C
authors.lastname: Fortini
mesh_terms: D000328:Adult; D000368:Aged; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D007370:Interferon Type I / Q000627:therapeutic use*; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008545:Melanoma / Q000628:therapy*; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011994:Recombinant Proteins; D012878:Skin Neoplasms / Q000628:therapy*
chemical_list: D007370:Interferon Type I; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins