The success of autologous marrow transplantation (AMT) for the treatment of patients with hematologic malignancy is limited largely by a high incidence of disease recurrence after AMT. IL-2 with or without adoptive immunotherapy in the form of ex vivo-generated lymphokine-activated killer (LAK) cells, has induced regression of advanced cancer in some patients, including, primarily, some with hematologic malignancies. This approach could potentially represent a treatment modality which would be non-cross- resistant with chemoradiotherapy conditioning regimens for AMT. IL-2+LAK cells has been used mostly in the presence of large tumor burdens. Our goal is to test the hypothesis that this approach, if used early after AMT in a setting of minimal residual disease, may reduce the posttransplant relapse rate. We have demonstrated that IL-2-responsive LAK precursor cells appear in the circulation early after AMT. We have identified an IL- 2 regimen which is tolerable when administered early after AMT and induces immunomodulatory effects. We have begun to test the feasibility of administering IL-2 plus LAK cells early after AMT. The goals of the studies proposed are to establish a treatment regimen of IL-2 and autologous LAK cells which can be applied to the majority of patients early after AMT for acute leukemia and malignant lymphoma and then to determine the effect of such a regimen on posttransplant relapse rates. Accordingly, the specific aims of this proposal are as follows: 1) to establish the feasibility of administering a regimen of IL-2 and autologous LAK cells early to the majority of patients undergoing AMT for hematologic malignancies, and to compare the relapse rates in patients so treated with appropriate historical controls, and 2) based on the above trial, to conduct a randomized controlled trial of IL-2 and LAK cells versus no consolidative therapy after AMT in patients at high risk for relapse for hematologic malignancies to determine the effect, if any, on the relapse rate.
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