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

Omer Kucuk, Mary L. Young, Thomas M. Habermann, Barbara C. Wolf, Jose Jimeno, Peter A. Cassileth

Research output: Contribution to journalArticle

35 Scopus citations

Abstract

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 patients with NHL who relapsed or progressed after receiving one or two previous chemotherapy regimens. Fifty-one eligible patients were registered on this phase II study. Twenty-nine patients had intermediate or high grade (IG/HG) disease and 22 patients had low grade (LG) disease. Twenty-five patients received didemnin B at a dose of 6.3 mg/m2 and the remainder received 5.6 mg/m2, administered intravenously every 28 days. The patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 and biopsy-proven relapsed disease. Objective responses were observed in two (7%) patients (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. Patients 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. Didemnin B appears to have modest activity in low grade NHL. However, the drug has considerable toxicity in this population of patients.

Original languageEnglish (US)
Pages (from-to)273-277
Number of pages5
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume23
Issue number3
DOIs
StatePublished - Dec 1 2000

Keywords

  • Chemotherapy
  • Didemnin B
  • Non-Hodgkin's lymphoma

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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