A phase II trial of bryostatin-1 for patients with metastatic renal cell carcinoma

BACKGROUND, Patients with metastatic renal cell carcinoma have a poor progn osis and no standard therapy is available. The authors performed a Phase II trial of the novel agent bryostatin-1 in this patient population. METHODS. In all, 30 patients with measurable, previously untreated metastat ic renal cell carcinoma were studied. Patients had excellent physiologic re serve and preserved performance status. Bryostatin-l (25 mu g/m(2)) was giv en in the(polyethyleneglycol, ethanol, and Tween 80) formulation as a 30-mi nute intravenous infusion on Days 1, 8, and 15 of each 28-day cycle. In gen eral, treatment was continued until disease progression. RESULTS. Two patients had significant objective responses, although methodo logic problems made interpretation difficult. The median time to progressio n for all patients was 2.1 months; the median overall survival was 13.1 mon ths. The treat ment was generally well tolerated. Myalgia was the most comm on adverse event. One patient died while on study. This was a sudden death for a patient receiving a 15th cycle of therapy. Aside from this patient (f or whom the correlation of study drug to death was not clear), no Grade 4 n onhematologic toxicity was encountered in more than 150 treatment courses d elivered. CONCLUSIONS, There is minimal, if any, clinically relevant single-agent act ivity of bryostatin-1 at this dose and schedule for patients with metastati c renal cell carcinoma. (C) 2000 American Cancer Society.