Phase II trial of didemnin B in previously treated non-Hodgkin's lymphoma - An Eastern Cooperative Oncology Group (ECOG) study

Patients with non-Hodgkin's lymphoma (NHL) who fail initial therapy have a poor prognosis. We conducted a phase II study to determine the efficacy and toxicity of didemnin B, a non-myelosuppressive marine compound, in patient s with NHL who relapsed or progressed after receiving one or two previous c hemotherapy regimens. Fifty-one eligible patients were registered on this p hase II study. Twenty-nine patients had intermediate or high grade (IG/HG) disease and 22 patients had low grade (LG) disease. Twenty-five patients re ceived didemnin B at a dose of 6.3 mg/m(2) and the remainder received 5.6 m g/m(2), administered intravenously every 28 days. The patients had an Easte rn Cooperative Oncology Group (ECOG) performance status of 0-2 and biopsy-p roven relapsed disease. Objective responses were observed in two (7%) patie nts (one complete remission [CR] and one partial remission [PR]) with IG/HG disease and five (23%) patients (one CR and four PR) with LG disease. Pati ents with IG/HG disease had a median time to treatment failure (TTF) of 1.6 months and a median survival of 8.0 months. In contrast, the group with LG disease had a median TTF of 4.6 months and a median survival of 2.7 years. There were five grade V, 12 grade IV, and 57 grade III toxicities. Didemni n B appears to have modest activity in low grade NHL. However, the drug has considerable toxicity in this population of patients.