drugset / Trial / NCT00074269

Allogeneic Stem Cell Transplant After ATG, High-Dose Melphalan, and Fludarabine for Patients With Breast Cancer

NCT00074269

NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Giving chemotherapy, such as fludarabine and melphalan, before a donor peripheral blood stem cell transplant helps stop the growth of tumor cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining tumor cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving antithymocyte globulin, cyclosporine, and methotrexate before or after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well antithymocyte globulin, high-dose melphalan, fludarabine, and allogeneic peripheral stem cell transplant work in treating patients with metastatic adenocarcinoma of the breast.

Timeline

Start
2003-07
Primary completion
2008-03
Completion
2008-03

Drugs

EvaluationDrugModalityDoseRoute
Subject ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) Protein / enzyme biologic Intravenous
Subject Fludarabine Small molecule Intravenous
Subject Melphalan Small molecule Intravenous
Subject therapeutic allogeneic lymphocytes Cell therapy Other
Background Cyclosporine Peptide Intravenous
Background Methotrexate Small molecule Intravenous
Background filgrastim Protein / enzyme biologic Intravenous

Indications