Phase I study of immunotherapy by live Brucella abortus (strain 19 BA) in cancer patients

Twenty-eight patients showing negative responses against Brucella antigens were included in a preliminary trial of immunotherapy by a live Brucella abortus vaccine. Seventeen patients had squamous cell lung carcinoma, eight had acute myeloid leukemia, and three were classified as "others." Brucella abortus strain 19 BA was administered sc in a single injection at doses ranging from 5 X 10(7) viable organisms to 10(10), ie, 40 times the usual vaccine dose. No important toxicity was noted. Edematous reactions at the injection site and febrile responses were infrequent and moderate, hemocultures were all negative, spleen volume did not vary significantly, and cbc showed an increase of polymorphonuclear cells and lymphocytes.