Abstract
2076 Introduction: Kahalalide F (KF) is one of a family of novel dehydroaminobutyric acid-containing peptides isolated from the Hawaiian herbivorous marine species of mollusk, Elysia rufescens, with preclinical selective activity against androgen independent prostate tumors. The objectives of this study were to identify the maximum tolerated dose, to explore the toxicities, pharmacokinetics (PK) and anti-tumor activity of KF. Methods: KF is administered as a one-hour i.v. infusion, daily*5 every three weeks in patients with advanced or metastatic androgen refractory prostate cancer with progressive disease prior to entry. The starting dose was 20 μg/m2/day. Bioanalysis of KF was performed during the first and second course by LC-MS/MS. PSA levels of each patient were also evaluated to determine activity of KF. Results: 33 patients were registered with a median age of 68 years (range 49–81) and median WHO PS 1 (range 0–2). One patient per level was entered at 20, 40, 80 and 160 μg/m2/day. Due to reversible...
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