Clinical Phase I investigation of intravenous oil attached mycobacterial components as immunotherapeutic agents.

The toxicity and immunological effects of suspensions of mycobacterial cell wall skeleton (CWS) and trehalose dimycolate (TDM) attached to oil droplets and given intravenously in doses of 100 to 200 micrograms/M2 every one or two weeks was investigated. The major limiting side effect was fever and chills at a dose of 2 mg/M2. There was no major hematopoietic, renal, hepatic toxicity, or pulmonary toxicity. Intravenous therapy with CWS/TDM/Oil was associated with complete regression of a bronchial squamous cell arcinoma in one of three patients receiving 2000 micrograms/M2 weekly. The continued development and clinical study of surface attached purified and/or synthetic microbial adjuvants is a promising area of investigation.