Phase II study of weekly Kahalalide F in patients with advanced malignant melanoma.
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| Abstract |
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.
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| Authors | Salvador Martín-Algarra, Enrique Espinosa, Jordi Rubió, Juan José López López, José Luis Manzano, Lorenzo Alonso Carrión, Arrate Plazaola, Adnan Tanovic, Luis Paz-Ares |
| Journal | European journal of cancer (Oxford, England : 1990) (Eur J Cancer) Vol. 45 Issue 5 Pg. 732-5 (Mar 2009) ISSN: 1879-0852 [Electronic] England |
| PMID | 19186051 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't) |
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