A membrane-enriched extract of a virus-infected vulvar carcinoma cell line was evaluated as adjunctive immunotherapy in 16 patients who had vulvar carcinoma with lymph node metastases. Thirteen patients also received adjunctive radiation therapy based on individually assessed risk factors. Two patients developed progressive disease. The median disease-free survival for the group was 26+ months, as compared with nine months for a historical group that had undergone surgery alone and 16 months for a second group that had received surgery and adjunctive radiation therapy. The median disease-free survival of the immunotherapy group was longer than that of either of the two historical groups. Over 400 doses of extract, each equivalent to 1.5 mg protein, were administered without significant side effects. Evidence is presented for humoral and cellular augmented immune reactivity. The authors suggest that this approach be evaluated further to determine its efficacy in preventing recurrence in selected high-risk patients who have vulvar carcinoma.