Phase I-II clinical trial of gallium nitrate (NSC-15200)

Abstract

Gallium nitrate (NSC-15200), a group IIIa metal salt, was evaluated in a phase I-II clinical trial, In phase I trial, exploring bolus administration of the drug at 3-week intervals, dose-limiting renal toxicity was observed at doses exceeding 700 mg/m2. Hematological toxicity was minimal. Ototoxicity was observed in one patient. A phase-II trial was initiated evaluating the drug at 700 mg/m2 given at 2- and 3-week intervals. Antitumor responses were observed in one patient with soft-tissuesarcoma and in two patients with small cell carcinoma of the lung. In two of these responders, pretreatment 67Ga scan was positive. Further clinical trials with the drug appear indicated, utilizing the every 2 week schedule. Pretreatment hydration combined with osmotic diuresis may ameliorate potential nephrotoxicity.