Clinical studies with tubercidin administered after absorption into human erythrocytes.

Abstract

Tubercidin with EDTA has been given a Phase I clinical trial in 45 patients. The drug was mixed with approximately 500 ml blood withdrawn from the patient, with EDTA as an anticoagulant, and after 1 hr incubation at 37°, given intravenously to the patient. The dose levels ranged from 200 to 1500 μg/kg given at weekly intervals for two doses. Toxicity to the drug was uncommon and usually not severe. Hematological toxicity was noted in six patients, renal toxicity in five patients, hepatic toxicity in two patients, and severe gastrointestinal toxicity in one patient. Objective regression of the tumor was noted in four patients. The biological effect was apparent between 4 and 12 weeks after onset of therapy and was transitory.