Phase I trial of spirogermanium given by infusion in a multiple-dose schedule

In a phase I study of spirogermanium, a new azaspiran-germanium compound, 28 patients were given a multiple-dose schedule. When infused over 1 hour, the maximum tolerated single dose of this agent was greater than 120 mg/m2 but significant chronic neurologic toxicity occurred after 1-2 weeks of treatment. Patients with a poor performance status (PS) were the most likely to manifest toxic reactions. Suggested phage II dose levels for infusion treatment with spirogermanium are 120 mg/m2 for patients with a PS of 0-2 and 80 mg/m2 for patients with a PS of 3.