PHASE-II STUDY OF ELSAMITRUCIN (BMY-28090) FOR THE TREATMENT OF PATIENTS WITH REFRACTORY RELAPSED NON-HODGKINS-LYMPHOMA/

Purpose: To determine the response rate of patients with refractory/re lapsed non-Hodgkin's lymphoma to treatment with elsamitrucin and to fu rther characterize the toxic effects of elsamitrucin in this group of patients. Patients and methods: Eligibility required pathologically ve rified relapsed or refractory non-Hodgkin's lymphoma with no more than two prior chemotherapy regimens for patients with tumors classified b y the International Working Formulation (IWF) as A-C and no more than one prior chemotherapy for those with IWF grades D-G. Patients were en tered with either normal or impaired bone marrow function, but normal liver function tests were required unless clearly related to lymphomat ous involvement of the liver. Elsamitrucin 25 mg/m(2) was administered intravenously over 5-10 minutes weekly. Results: Thirty-one patients entered the study and were treated for a median of six weeks (range 1- 42). All patients were evaluable for toxicity and 30 for response. Mil d nausea and/or vomiting and asthenia were the most frequently reporte d adverse events. Four (13%, 95% CI 4.4-31.6%) partial responses were seen along with two (7%) minor responses while 9 (30%) patients had st able disease. Conclusion: Elsamitrucin showed modest activity in patie nts with relapsed or refractory non-Hodgkin's lymphoma. Toxicity was r elatively mild, consisted mainly of asthenia, nausea and vomiting and did not include myelosuppression. The activity of elsamitrucin in this group of patients and its lack of myelosuppression suggest utility in this disease especially when combined with other proven agents.