Rini, Brian I.Halabi, SusanBarrier, RobertMargolin, Kim A.Avigan, DavidLogan, TheodoreStadler, Walter M.McCarthy, Philip L.Linker, Charles A.Small, Eric J.2022-12-082022-12-082006-07-01Rini, B. I., Halabi, S., Barrier, R., Margolin, K. A., Avigan, D., Logan, T., Stadler, W. M., McCarthy, P. L., Linker, C. A., & Small, E. J. (2006). Adoptive Immunotherapy by Allogeneic Stem Cell Transplantation for Metastatic Renal Cell Carcinoma: A CALGB Intergroup Phase II Study. Biology of Blood and Marrow Transplantation, 12(7), 778–785. https://doi.org/10.1016/j.bbmt.2006.03.0111523-6536https://hdl.handle.net/1805/30695A graft-versus-tumor effect through nonmyeloablative allogeneic stem cell transplantation (N-SCT) in metastatic renal cell carcinoma (RCC) has been reported. An Intergroup phase II trial was undertaken to define further the feasibility, toxicity and efficacy of this approach in a multi-institutional setting, Patients with cytokine-refractory, metastatic RCC were treated with N-SCT. The conditioning regimen was fludarabine 30 mg · m−2 · d−1 on day (d) −7 through d −3 and cyclophosphamide 60 mg · kg−1 · d−1 on d −4 and d −3. Patients received 2-8 × 106 CD34+ cells/kg of granulocyte colony-stimulating factor mobilized stem cells from a 6/6 HLA-matched sibling donor. Immunosuppression after transplantation included tacrolimus and methotrexate. Twenty-two patients were enrolled at 14 institutions. Greater than 90% donor T-cell chimerism was observed in 17 of 19 evaluable patients (89%) by d +120. No objective response was observed. Acute graft-versus-host disease (GVHD) was observed in 11 patients (50%). Chronic GVHD was reported in 5 patients (23%). There was 1 patient death from liver failure secondary to chronic GVHD. Regimen-related mortality was 2 of 22 (9%; liver failure, sepsis). Median survival time was 5.5 months (95% confidence interval, 3.9-12.0 months) and the median time to progression was 3.0 months (95% confidence interval, 2.3-4.2 months). N-SCT for metastatic RCC is feasible in a multi-institutional setting. Adequate donor T-cell engraftment was achieved in most patients before disease progression. A graft-versus-tumor effect was not observed in this study despite acute and chronic GVHD, thus highlighting the need for further understanding of this approach. Allogeneic SCT remains investigational in RCC.enAttribution-NonCommercial-NoDerivatives 4.0 InternationalAllogeneicNonmyeloablative transplantRenal cell carcinomaArticle