Surgical adjuvant therapy of malignant melanoma with corynebacterium parvum.

The authors' previous surgical adjuvant trial in patients with malignant melanoma at high risk of recurrence has shown no difference in disease-free interval or survival between patients randomized to surgery + BCG or surgery alone. Reported here is a subsequent nonrandomized trial in 30 similar patients who received surgery + Corynebacterium parvum (CP) 4 mg I.V. daily x 5, followed by 4 mg S.C. weekly for up to three years. After I.V. C. parvum, chills, fever, headache, and hypertension were common. After S.C. C. parvum, varying degrees of local induration, erythema, and pain were experienced. Dose reduction was necessary for 14 patients during I.V. treatment and for six patients during S.C. treatment. A marked decrease in absolute lymphocyte count and a decreased proliferative response of lymphocytes to common antigens in vitro was observed after 2-3 days of I.V. C. parvum. Lymphocyte reactivity to mitogens decreased, particularly with Con A. Marked increase in nitroblue tetrazolium reduction by granulocytes was seen in 20 patients. Although changes in delayed cutaneous hypersensitivity reactions to recall antigens followed no consistent pattern, reactivity to DNCB increased in 18 patients. In addition, median time to recurrence was 33 weeks, significantly shorter than in the previous trial, but the survival distribution was no different from before. It can be concluded, therefore, that the administration of C. parvum in this dose and schedule had essentially no effect on the outcome of these patients.

RCT Entities:   Population Interventions Outcomes