Phase I-II study of piperazinedione in adults with solid tumors and acute leukemia.
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| Abstract |
Piperazinedione was administered to 79 patients with solid tumors on an intermittent schedule with single doses of 1.5-36 mg/m2. Courses were usually repeated at 4-week intervals. Twenty-five patients with leukemia were treated at doses of 18-36 mg/m2 (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/m2 for patients with risk factors for marrow aplasia, 12 mg/m2 for patients with prior therapy, 15 mg/m2 for previously untreated patients, and 24-36 mg/m2 for patients with acute leukemia.
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| Authors | 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 |
| Journal | Cancer treatment reports (Cancer Treat Rep) Vol. 63 Issue 6 Pg. 939-43 (Jun 1979) ISSN: 0361-5960 [Print] United States |
| PMID | 380802 (Publication Type: Clinical Trial, Journal Article, Research Support, U.S. Gov't, P.H.S.) |
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