Allogeneic Breast Protocol 1: T-Cell Depleted Allogeneic Blood Stem Cell Transplantation Using an Immunoablative Conditioning Regimen in Metastatic Breast Cancer
- Determine the ability of T-cell-depleted allogeneic blood stem cell transplantation
after an immunoablative conditioning regimen to induce a state of mixed host/donor
chimerism in patients with metastatic breast cancer.
- Determine the ability of this treatment regimen to induce an allogeneic
graft-versus-tumor response in these patients.
- Determine the feasibility of giving other approved therapies to these patients at the
first sign of disease progression in order to stabilize or produce a minimal or partial
OUTLINE: Patients receive chemotherapy comprising fludarabine IV over 30 minutes and
cyclophosphamide IV over 1 hour on days 1-4. Patients receive filgrastim (G-CSF) SC daily
beginning on day 5 and continuing until blood counts recover. Treatment repeats every 21
days for a maximum of 2 courses.
Patients receive a transplantation preparative regimen comprising fludarabine IV over 30
minutes and cyclophosphamide IV over 2 hours on days -6 to -3 (beginning on day 22 of
immune-depleting chemotherapy) followed by allogeneic peripheral blood stem cell
transplantation IV on day 0. Patients receive G-CSF SC daily beginning on day 0 and
continuing until blood counts recover, plus cyclosporine IV over 1-2 hours every 12 hours on
days -1 to 14 and then orally until day 40.
Patients with persistent malignant disease and less than grade II acute graft-versus-host
disease receive donor lymphocytes IV on days 42, 70, and 98.
Patients are followed twice weekly until day 100, and then at 6, 9, 12, 18, and 24 months.
PROJECTED ACCRUAL: A maximum of 70 patients will be accrued for this study within 24 months.
Masking: Open Label, Primary Purpose: Treatment
Michael R. Bishop, MD
National Cancer Institute (NCI)
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|
|NCI - Center for Cancer Research||Bethesda, Maryland 20892|