Phase II study of weekly Kahalalide F in patients with advanced malignant melanoma
S. Martín-Algarra (a), E. Espinosa, J. Rubió, J. López, J. Manzano, L. Carrión, A. Plazaola, A. Tanovic, L. Paz-Ares
This phase II clinical trial evaluated the antitumour response of Kahalalide F (KF) 650 microg/m(2) 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 chemotherapy-naïve patients with cutaneous melanoma had disease stabilisation for > or = 3 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.
CITATION Eur J Cancer. 2009 Mar;45(5):732-5