Abstract

A phase I study of recombinant gamma-interferon (LBD-001) was conducted in 23 patients with advanced malignancy. The schedule was the intramuscular administration of recombinant interferon-gamma 6 consecutive days a week for 2 weeks followed by 2 weeks of rest and was repeated every 28 days. Patients were assigned to six dose levels. The maximum tolerated dose was 10.0x10(6) units/m/day and the major toxicities were flulike symptoms. After intramuscular injection, the pharmacological data fit the single compartmental modeL More than 2/3 of the dose administered was absorbed. The absorbance T 1/2 was longer with values of 247.6 minutes but interferon-gamma was cleared with a short half life of 49.9 minutes from the circulation. Antitumor effects occurred in patients with chronic myelogenous leukemia and malignant melanoma.