Aerosol BCG treatment of carcinoma metastatic to the lung: a phase I study.

BCG (TICE) was safely administered to 15 patients with metastatic cancer to the lungs in weekly doses of up to 3 X 107 organisms by the aerosol route. The aerosol route of administration is associated in approximately 33% of the doses with a toxicity syndrome of malaise, fever, and chills beginning 4 to 8 hours after treatment and ending within 24-36 hours. This syndrome is experienced by all patients and symptoms gradually subside with continuation of therapy. No hepatic or pulmonary toxicity was documented during the 221 treatment doses.