DIDEMNIN-B IN FAVORABLE HISTOLOGY NON-HODGKINS-LYMPHOMA - A PHASE-II STUDY OF THE NATIONAL-CANCER-INSTITUTE OF CANADA CLINICAL-TRIALS GROUP

Ten patients with previously untreated stage III/IV low grade histolog y non-Hodgkin's lymphoma received a 1-hour intravenous infusion of Did emnin B 2.3 mg/m(2) weekly for 4 weeks repeated every 6 weeks. 40% of patients experienced significant hypersensitivity reactions, one of wh ich was life-threatening, despite premedication with diphenhydramine a nd cimetidine. Other toxicities included nausea, vomiting, fatigue, di arrhea and skin rashes. No objective responses were seen. Given the se rious toxicity and lack of activity in a non-pretreated group of patie nts, the study was closed early. Further investigation of Didemnin B a t this dose and schedule is not recommended.