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[Allogeneic transplantation of peripheral blood hematopoietic stem-cells with low intensity conditioning for the treatment of a metastatic clear cell carcinoma. Preliminary results after two years of follow-up].

OBJECTIVES
To evaluate the toxicity and outcomes of the allogeneic transplantation of peripheral blood hematopoietic stem-cells with low intensity conditioning (mini-alo Bone Marrow transplantation-BMT) in metastatic renal cell carcinoma refractory to at least one line of systemic treatment.


METHODS
From 30 patients submitted to the Sant Pau's Hospital for immunotherapy between 1/2001 and 1/2003, six patients finally underwent mini-alo BMT within a clinical trial. Conditioning: Fludarabine: 30 minute i.v. infusion of 13 mg/m2 on days -9, -8, -7, -6 and -5. Busulfan: 1 mg/kg (real weight) q 6 hours, PO on days -6, -5, and -4 (4 doses per day on days -6 and -5, and 2 doses only on day -4, total number of doses 10).


RESULTS
Two patients achieved partial response, one patient stabilized disease, and two patients had progression on days +30 and +60. Therefore, 2/3 patients surviving more than six months achieved partial response. One patient died on day +30 after acute hepatic graft-versus-host disease. Complete chimerism was demonstrated in all patients.


CONCLUSIONS
The mimni-alo BMT is feasible in patients with metastatic renal cell carcinoma and provides objective responses, although its efficacy should be confirmed by phase III clinical trials.