Over the past 7 years, 151 patients with malignant melanoma have been treated 
with BCG immunotherapy alone or as an adjunct to surgical therapy. Direct 
injection of metastatic melanoma lesions limited to skin resulted in 90% 
regression of injected lesions and 17% regression of uninjected lesions in 
immunocompetent patients. Approximately 25% of these patients remained free of 
disease for 1 to 6 years. Direct injections of BCG into nodules of patients with 
subcutaneous or visceral metastases resulted in a lower incidence of local 
control and no long term survivors. Attempts to improve the results of 
immunotherapy in these patients by palliative surgical resection of large 
metastatic lesions to lower tumor burden followed by BCG immunotherapy 
significantly improved the results although many patients still developed 
recurrent disease. Early results of a clinical trial combining BCG immunotherapy 
with regional lymphadenectomy in patients with melanoma metastatic to lymph 
nodes have been encouraging and promising. Further controlled clinical trials 
are necessary to elucidate the role of BCG in immunotherapy. However, since BCG 
is but one of a number of potential immunologic adjuvants, even more effective 
immunotherapy will be possible as further knowledge of the interactions of 
cellular and humoral immunity is acquired.