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Phase I–II study of intralesional immunotherapy with oil-attached Mycobacterium smegmatis cell wall skeleton and trehalose dimycolate

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The clinical toxicity and efficacy of intralesional immunotherapy with a nonviable mycobacterial vaccine consisting of Mycobacterium smegmatis cell wall skeleton (CWS) and trehalose dimycolate (P3) attached to oil droplets was investigated. Thirty-four patients received a total of 192 infections, the doses ranging from 150 μg CWS and 75 μg P3 to 1200 μg CWS and 600 μg P3. Treatment was well tolerated. Mild fever and chills occurred in approximately 70% of treatments. There was no discernible effect on hematologic, renal, or hepatic parameters.

Of the 34 patients, CWS/P3 therapy was clinically effective in seven with metastic malignant melanoma in causing regression of the infected lesion. Four of these seven patients also had an objective response of noninjected lesions by over 50%. Pulmonary metastatis responded in one patient. CWS/P3 therapy caused an increase in the skin test response of 14 of the patients to CWS antigen. There was no measurable consistent change in reactivity to recall antigens, T or B cell populations, PHA response, or serum proteins associated with the intralesional CWS/P3 therapy.

Nonviable CWS/P3 is an effective agent for human immunotherapy. This and other purified bacterial components warrant continued investigation as single agents in clinical immunotherapy trials.

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Correspondence to G. Vosika.

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Vosika, G., Schmidtke, J., Goldman, A. et al. Phase I–II study of intralesional immunotherapy with oil-attached Mycobacterium smegmatis cell wall skeleton and trehalose dimycolate. Cancer Immunol Immunother 6, 135–142 (1979).

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  • Malignant Melanoma
  • Trehalose
  • Metastic Malignant Melanoma
  • Mycobacterium Smegmatis
  • Bacterial Component