Phase I trial of dihydroxyanthracenedione

Dihydroxyanthracenedione was given to 16 patients with solid tumors in a phase I clinical trial. The dose schedule used was a single daily dose for 3 consecutive days given every 3 weeks. The amount given ranged from 2 to 5 mg/m²/day. The dose-limiting toxic effect was moderate to severe leukopenia which occurred at a dose ≥ 4 mg/m²/day x 3. Thrombocytopenia was infrequent and did not require transfusion. Nonhematologic side effects were insignificant and included nausea, vomiting, and green-tinged urine. A minor tumor response was noted in a patient with fibrosarcoma. The recommended doses for solid tumor phase II studies are 4 mg/m²/day x 3 for good-risk patients and 3 mg/m²/day x 3 for poor-risk patients, given every 3 weeks.