Background: Active specific immunotherapy with Newcastle disease virus-modified autologous tumor cells (ASI) is able to induce a tumor-specific T-cell-dependent immune response. It was the aim of the following study to increase the clinical effect of ASI using a combination therapy with lymphokine-activated killer cells generated from tumor-infiltrating lymphocytes (LAK-TIL) and high-dose rIL 2. Material and Methods: In 6 disseminated breast and 11 ovarian cancer patients FIGO III and IV TIL were generated from lymph nodes or ascites and pleural effusions and activated using rIL 2. After the ASI procedure and a cyclophosphamide treatment LAK-TIL were injected succeeded by a high-dose rIL 2 therapy for 120 h. Results: After immunotherapy an increase of cytolytic activity in the 51Cr release test against K 562 cells to 49% and an increase of CD 16-positive cells from 7 to 42% could be demonstrated. The rIL 2 therapy was accompanied by severe side effects including fever, erythematous rush, edema and so on. In the mean time of observation of 23 months seven complete or partial remissions, three stable diseases and five progressions were observed. The duration of response was 5 months and afterwards all women progressed again. Conclusions: Although this form of immunotherapy can possibly cause regression it is too early to determine the effect of this therapy on survival. As in addition this therapy is accompanied by severe side effects and the methods required are laborious this treatment should be considered highly experimental.

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