Exploratory Study of Non-Myeloablative Allogeneic Peripheral Blood Stem Cell and Donor Lymphocyte Infusions for Metastatic Neoplasms Refractory to Standard Therapy
- Identify an anti-tumor effect of allogeneic peripheral blood stem cell transplantation
by induction of a graft-versus-tumor effect in patients with a diversity of metastatic
solid tumors refractory to standard therapy.
- Determine engraftment in these patients.
- Determine the effects of donor lymphocyte infusion and cyclosporine withdrawal on tumor
regression in these patients.
OUTLINE: Patients are stratified according to risk of graft rejection, which determines the
preparative regimen received. High-risk patients include heavily transfused patients or
patients who have received donor-directed blood products and single HLA-locus mismatched
Preparative regimen: Patients receive cyclophosphamide IV over 1 hour on days -7 and -6 and
fludarabine IV over 30 minutes on days -5 to -1. Patients at high risk also receive
antithymocyte globulin IV on days -5 to -2.
Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. Patients
receive cyclosporine either by continuous infusion IV or orally twice a day on days -4 to
100 as graft-versus-host disease (GVHD) prophylaxis.
Patients with less than 100% donor T-cell chimerism or with evidence of tumor progression
receive donor lymphocytes after day 100, every 4 weeks, until 100% donor T-cell chimerism,
disease regression, and/or GVHD occurs.
Patients are followed at 4, 6, 8, 10, and 12 months, every 3 months for 2 years, and then
every 6 months for 2 years.
PROJECTED ACCRUAL: Approximately 150 patients (10 for each cancer) will be accrued for this
Primary Purpose: Treatment
Tumor response (i.e., complete response, partial response, stable disease, or progressive disease)
Richard W. Childs, MD
National Heart, Lung, and Blood Institute (NHLBI)
United States: Federal Government
|NIH - Warren Grant Magnuson Clinical Center||Bethesda, Maryland 20892-1182|