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Modified Donor Peripheral Blood Stem Cells in Combination with Zoledronic Acid for the Treatment of Pediatric, Adolescent, and Young Adult Patients with Relapsed or Refractory Solid Tumors

Trial Status: active

This phase I/II trial tests the safety and effectiveness of αβ-T cell and CD19+ B cell depleted allogeneic peripheral blood stem cells followed by zoledronic acid in treating pediatric, adolescent, and young adult patients with solid tumors that have come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). A common risk with stem cell transplants is graft-versus-host-disease, which occurs when donor cells see the patient's normal cells as foreign and attack them. Removing certain types of immune cells (such as αβ-T cells and CD19+ B cells) from the donor product before the transplant may prevent or reduce the risk of patients developing graft-versus-host-disease. The αβ-T cell and CD19+ B cell depleted allogeneic peripheral blood stem cell product is made by collecting peripheral blood stem cells from donors and removing the αβ-T cells and CD19+ B cells. When infused into the bloodstream, the healthy donor cells can grow and make new red blood cells, white blood cells, and platelets. Conditioning chemotherapy with thymoglobulin, fludarabine, thiotepa, and melphalan is given before the donor cell infusion in order to prepare the patient's bone marrow to receive the donor cells. Zoledronic acid is a type of bisphosphonate. It is approved to treat malignant hypercalcemia and used to prevent fractures in multiple myeloma and treat solid tumor-associated bone metastases in adults. Combining αβ-T cell and CD19+ B cell depleted allogeneic peripheral blood stem cell transplant with zoledronic acid may improve treatment outcomes and reduce the risk of developing treatment side effects like graft-versus-host-disease in pediatric, adolescent, or young adult patients with relapsed or refractory solid tumors.