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
(a) Clínica Universitaria de Navarra, Avda. Pío XII, 36, 31008 Pamplona, Spain
(b) Hospital la Paz, Madrid, Spain
(c) Hospital Josep Trueta, Girona, Spain
(d) Hospital Sant Pau, Barcelona, Spain
(e) Hospital Germans Trias i Pujol, Badalona, Spain
(f) Hospital Clínico Virgen de la Victoria, Málaga, Spain
(g) Instituto Oncológico de San Sebastián, San Sebastián, Spain
(h) Pharma Mar S.A., Colmenar Viejo, Madrid, Spain
(i) Hospital 12 de Octubre, Madrid, Spain
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