Phase II study of weekly Kahalalide F in patients with advanced malignant melanoma

• DOI: 10.1016/j.ejca.2008.12.005
• Publication Date: 2009-01-30T09:51:42Z
• Authors: Salvador Martín-A...; Enrique Espinosa; Jordi Rubió; Juan José López L...; José Luis Manzano; Lorenzo Alonso Ca...; Arrate Plazaola; Adnan Tanovic; Luis Paz-Ares
• Keywords: Adult; Aged, 80 and over; Male; 0301 basic medicine; Skin Neoplasms; Antineoplastic Agents; Middle Aged; Kahalalide F (KF); 3. Good health; 03 medical and health sciences; Treatment Outcome; Depsipeptides; Chemotherapy; Metastatic; Humans; Female; Melanoma; Aged

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.