Phase II study of Didemnin B in central nervous system tumors: A SouthwestOncology Group study

Didemnin B 6.3 mg/m(2) was administered intravenously to 48 patients with r ecurrent or progressive central nervous system tumors. One patient of 39 (2 .9%, 95% confidence limits 0.1 to 13.5) eligible patients had a confirmed p artial response utilizing standard solid tumor criteria which lasted 14 mon ths. Toxicity was significant. Nausea and vomiting and lethargy were the mo st frequent toxicities, but multiple severe toxicities were seen. Further i nvestigation of Didemnin B at this dose is not warranted in patients with c entral nervous system malignancies.