Sixty-one patients with stage I or II (lymph node involvement) malignant melanoma were prospectively randomized into a control group receiving surgical treatment only (consisting of wide excision of primary and regional node dissection) and a group receiving the same surgical treatment plus adjuvant therapy with DTIC and Corynebacterium parvum. Followup times ranged from 1 1/2 to 4 years. Among the 29 patients in the surgical control group, there were five hematogenous recurrences and one regional recurrence and four patients have died. Among the 32 patients in the treatment group, there were 13 hematogenous recurrences and two regional recurrences and ten patients have died. However, the control group had six patients with involved lymph nodes while the treatment group had 15 patients in this category. It appears that although the combination of DTIC and C. parvum was well-tolerated, it did not reduce the recurrence and mortality rates.