Nonmyeloablative Allogeneic Stem Cell Transplantation for the Treatment of Solid
The trial is a pilot study in which patients with metastatic solid tumors will undergo
non-myeloablative allogeneic hematopoietic stem cell transplantation. Patients whose
immunosuppressive therapy has been tapered off, are without GVHD, and have evidence of
residual or progressive disease will undergo DLI.
In recent years there have been attempts to harness the graft-versus-tumor effect of
allogeneic bone marrow transplant to treat patients with metastatic solid tumors.
Researchers at the NIH recently reported on 19 patients with refractory metastatic
renal-cell carcinoma who had suitable donors and received a preparative regimen of
cyclophosphamide and fludarabine followed by an infusion of a peripheral-blood stem-cell
allograft from an HLA-identical sibling or a sibling with a mismatch of a single HLA
antigen.49 They note that at the time of the last follow-up, 9 of the 19 patients were alive
287 to 831 days after transplantation (median follow-up: 402 days). Two had died of
transplantation-related causes and 8 of progressive disease. In 10 patients (53%) metastatic
disease regressed: 3 had a complete response, and 7 had a partial response. The patients who
had a complete response remained in remission 27, 25, and 16 months after transplantation.
Regression of metastases was delayed, occurring a median of 129 days after transplantation,
and often followed the withdrawal of cyclosporine and the establishment of complete donor
T-cell chimerism. They concluded that these results were consistent with a
graft-versus-tumor effect and that non-myeloablative allogeneic stem cell transplantation
can induce sustained regression of metastatic RCCA in patients who have had no response to
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the percent 100-day survival of patients with metastatic solid tumors undergoing non-myeloablative allogeneic stem cell transplantation (SCT).
David F McDermott, MD
Beth Israel Deaconess Medical Center
United States: Institutional Review Board
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