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Phase II study of weekly Kahalalide F in patients with advanced malignant melanoma
(Elsevier BV, 2009) Martin-Algarra, S. (Salvador); Plazaola, A. (Arrate); Manzano, J.L. (José Luis); López-López, J.; Carrión, L.A. (Lorenzo Alonso); Paz-Ares, L. (Luis); Espinosa, E. (Enrique); Tanovic, A. (Adnan); Rubio, J. (Jordi)
This phase II clinical trial evaluated the antitumour response of Kahalalide F (KF) 650 lg/m2 given as a 1-h weekly infusion in advanced malignant melanoma patients, both untreated and those who relapsed or progressed after one line of systemic therapy. Of 24 enrolled patients (median age, 55 years; range, 28–89), 14 patients had been previously treated with chemotherapy or biological therapy. No RECIST responses occurred; five chemotherapynaı¨ve patients with cutaneous melanoma had disease stabilisation for P3 months; median progression-free survival was 1.7 months (95% CI, 1.2–1.9 months); and median overall survival was 10.8 months (95% CI, 5.0-upper limit not reached). The most common laboratory toxicities were non-cumulative increase of transaminases (ALT/AST) and gamma-glutamyltransferase (GGT). No patients experienced leukopenia and thrombocytopenia during the study. KF was a well-tolerated and safe chemotherapy regimen. Despite a favourable safety profile, this trial was closed after the first stage because of the lack of objective response in patients with malignant melanoma