PHASE-II TRIAL OF PIPERAZINEDIONE IN HODGKINS-DISEASE, NON-HODGKINS LYMPHOMA, AND MULTIPLE-MYELOMA - SOUTHWEST ONCOLOGY GROUP STUDY

Piperazinedione given i.v. once every 3-4 wk at a starting dose of 9-12 mg/m2 (4.5-12 mg/m2 for patients with multiple myeloma) was evaluated in a Southwest Oncology Group phase II study for patients with advanced refractory lymphoma or multiple myeloma. Among 36 patients fully evaluable for tumor response (adequate trial), partial responses were obserbed in 5 (71%) of 7 pateints with Hogdkin''s disease, 3 (19%) of 16 patients with non-Hodgkin''s lymphoma and in none of 13 patients with multiple myeloma. Response was observed by the time of the 2nd (5 patients) or 3rd (3 patients) course. The median duration of response was 3.7 mo. (range, 1-17+ mo.). The dose-limiting toxic effects were hematologic, with 18 (50%) of 36 patients evaluable for toxicity experiencing severe leukopenia (wbc [white blood cell] count < 2000/mm3) and 22 (61%) experiencing severe thrombocytopenia (platelet count < 50,000/mm3). Twenty patients had a decrease from their pretreatment Hb level of .gtoreq. 2 g/100 ml. Hematologic toxic effects were often unpredictable and in several patients quite prolonged. This study indicates that piperazinedione has definite antitumor activity in patients with Hodgkin''s disease and further trials in this disease using the drug at a reduced dose in combination with other effective drugs appear warranted.