A phase II trial of PI-88, a novel antiangiogenic and antimetastatic heparanase inhibitor, in patients with advanced melanoma

7559 Background: PI-88 is a novel anti-angiogenic drug, which acts by inhibiting heparanase and binding to pro-angiogenic growth factors. This pilot study is designed to evaluate the safety and efficacy of PI-88 in patients (pts) with advanced melanoma where other effective therapy is not available or has failed. Methods: PI-88 250 mg/day was administered by subcutaneous injection on four consecutive days every week in a 28-day cycle. Tumour lesions were measured after every second cycle. Results: Forty-four pts have been enrolled with the following demographics: M:F ratio = 30:14; median age = 59 (range 29–79); ECOG 0:1:2 ratio = 29:13:2. The number of prior chemotherapy/biochemotherapy treatments 0:1:2+ was 19:21:4. 11 pts had prior immunotherapy (vaccine or interferon). 41 pts were evaluable for efficacy. Only 5 pts experienced Gr 3/4 toxicities; these were were brain hemorrhage in one pt in cycle 1 (associated with cerebral metastasis), thrombocytopenia (TCP) in 2 pts in cycle 1, arterial thrombosis (...