Journal
EUROPEAN JOURNAL OF CANCER
Volume 45, Issue 5, Pages 732-735Publisher
ELSEVIER SCI LTD
DOI: 10.1016/j.ejca.2008.12.005
Keywords
Chemotherapy; Kahalalide F (KF); Metastatic; Melanoma
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Funding
- Pharma Mar
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This phase II clinical trial evaluated the antitumour response of Kahalalide F (KF) 650 mu g/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-naive patients with cutaneous melanoma had disease stabilisation for >= 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. (C) 2008 Elsevier Ltd. All rights reserved.
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