Phase I evaluation of piperazinedione in patients with advanced cancer.

The effects of iv administered piperazinedione were studied in 28 evaluable adult and eight evaluable pediatric patients with advanced cancer. Piperazinedione produced predictable myelosuppression of moderate degree at dosages of 3--3.5 mg/m2/day X 5 days by iv injection. When given in this manner, nausea and vomiting did not occur. Single iv doses of 10--15 mg/m2 produced mild-to-moderate nausea and vomiting and mild myelosuppression. Thrombocytopenia was more severe than leukopenia in both schedules. The drug produced comparable dose-related effects in adults and children. Although no therapeutic response was observed in the adults, a partial remission of 6 months' duration was seen in one child with Hodgkin's disease.