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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 × 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.