PHASE-1 STUDY OF TAUROMUSTINE ADMINISTERED IN A WEEKLY SCHEDULE

Tauromustine was administered orally in weekly doses with interindivid ual dose escalation to patients with disseminated malignant melanoma. The dose in the first cohort of 6 patients was 20 mg/m2/week. The dose escalation was 5 mg/m2/week. The limit of tolerance was 55 mg/m2/week . 99 patients completed at least 8 weeks of treatment and eight dose l evels were evaluated for toxicity. Reversible thrombocytopenia, and to a lesser degree leukopenia, were dose limiting. From a starting dose of 40 mg/m2/week, the long-term tolerated dose was 35 mg/m2/week, thus achieving a considerable increase of dose intensity without a signifi cant increase of toxicity by employing this weekly schedule of tauromu stine.