Phase I-II study of piperazinedione in adults with solid tumors and acute leukemia

R. S. Benjamin, M. J. Keating, M. Valdivieso, K. B. McCredie, R. A. Livingston, M. A. Burgess, V. Rodriguez, G. P. Bodey, J. A. Gottlieb

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11 Scopus citations

Abstract

Piperazinedione was administered to 79 patients with solid tumors on an intermittent schedule with single doses of 1.5-36 mg/m 2. Courses were usually repeated at 4-week intervals. Twenty-five patients with leukemia were treated at doses of 18-36 mg/m 2 (occasionally for 2 successive days) every 1-4 weeks. Of 48 evaluable patients with malignant melanoma, three (6%) achieved partial remission and nine (20%) had stable disease. Eight of 17 (47%) patients with adenocarcinomas and one of two (50%) patients with lymphomas also had stable disease. Six of 14 (43%) patients with acute myelogenous leukemia showed hematologic improvement, as did one of 11 (9%) patients with blast cell crisis of chronic myelogenous leukemia. The principal toxic effect was myelosuppression, which occurred in 69% of the patients with solid tumors. Profound bone marrow aplasia occurred in 19% of the patients, resulting in six deaths (8%). Risk factors for marrow aplasia included extensive prior therapy, prior nitrosoureas, cumulative toxicity from piperazinedione, and abnormal liver function tests. The recommended doses for further studies are 9 mg/m 2 for patients with risk factors for marrow aplasia, 12 mg/m 2 for patients with prior therapy, 15 mg/m 2 for previously untreated patients, and 24-36 mg/m 2 for patients with acute leukemia.

Original languageEnglish (US)
Pages (from-to)939-943
Number of pages5
JournalCancer Treatment Reports
Volume63
Issue number6
StatePublished - Dec 1 1979

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Benjamin, R. S., Keating, M. J., Valdivieso, M., McCredie, K. B., Livingston, R. A., Burgess, M. A., Rodriguez, V., Bodey, G. P., & Gottlieb, J. A. (1979). Phase I-II study of piperazinedione in adults with solid tumors and acute leukemia. Cancer Treatment Reports, 63(6), 939-943.