We report on 208 patients with locally advanced renal-cell carcinoma who received a surgical adjuvant vaccination with autologous, Newcastle disease virus (NDV)-modified, and lethally irradiated tumor cells in combination with low-dose recombinant interleukin-2 and interferon-alpha. The pathological stage was defined as pT2-3a, N1-2, MO (n = 107); pT3b-4 NO, MO (n = 68); and pT3b-4, N1-2, MO (n = 23). The follow-up of 203 evaluable patients showed a median disease-free survival of 21+ months (range, 2-64+ months). In all, 18 relapses (9%) occurred in spite of initial vaccination therapy. Those patients presented with local relapse (n = 3), lymph node metastases (n = 10), and/or distant organ metastases (n = 9). All patients relapsing during the first 6 months after the onset of treatment had primary lymph node involvement of the disease. An analysis of the patient subgroup with a follow-up of more than 22 months showed 10 relapses among 56 patients (18%) along with a median follow-up of 39 months (range, 23-64 months). Toxicity was very mild, manifesting as flu-like symptoms and fevers of up to 38 degrees C. At 8 and 24 weeks after the start of vaccination, anti-NDV serum antibodies were detectable in 70% and 100% of the patients tested, respectively. In comparison with historical data based on the natural course of patients with locally advanced renal-cell cancer, our results demonstrate an improvement of the disease-free survival after surgical adjuvant treatment with autologous, NDV-modified tumor vaccines in combination with low-dose cytokines.