Neocarzinostatin: report of a phase II clinical trial.

Fifty-three patients received intensive treatment with neocarzinostatin in doses of 3500 units/m2 by iv bolus infusion daily for 5-14 days. The response rate for 22 patients with leukemia was 9%. One complete and one partial remission were observed among nine patients with chronic myelogenous leukemia in blast cell crisis. None of the 31 patients with solid tumors responded to treatment. With this dose schedule, prolonged thrombocytopenia and cumulative bone marrow toxicity limit the intensity and duration of neocarzinostatin therapy. Acute allergic reactions occurred in 28% of the treatment courses, and three patients developed anaphylaxis during the second or third course of therapy.