drugset / Trial / NCT00436761

Busulfan, Melphalan, and Antithymocyte Globulin Followed By Umbilical Cord Blood Transplant in Treating Young Patients With Refractory or Relapsed Malignant Solid Tumors

NCT00436761

Phase 1 Unknown 20 enrolled Milton S. Hershey Medical Center
Open-labelTreatment

Summary

RATIONALE: Giving chemotherapy before a donor umbilical cord blood stem cell transplant helps stop the growth of tumor cells. It also helps stop the patient's immune system from rejecting the donor's stem cells when they do not exactly match the patient's blood. The donated stem cells may replace the patient's immune cells and help destroy any remaining tumor cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and methylprednisolone after the transplant may stop this from happening. PURPOSE: This phase I trial is studying the side effects of busulfan, melphalan, and antithymocyte globulin followed by umbilical cord blood transplant in treating young patients with refractory or relapsed malignant solid tumors.

Timeline

Start
2004-05
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) Protein / enzyme biologic Intravenous
Subject Busulfan Small molecule Oral
Subject Melphalan Small molecule Intravenous
Background Cyclosporine Peptide Intravenous
Background Methylprednisolone Other / unclassified Intravenous
Background sargramostim Protein / enzyme biologic Subcutaneous