Phase II Trial of Non-Myeloablative Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation Using Fludarabine, Low-Dose TBI, and Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil (MMF) Followed by Donor Lymphocyte Infusion in Selected Patients With Metastatic Melanoma
- Determine the objective response rate in patients with metastatic melanoma treated with
nonmyeloablative allogeneic peripheral blood stem cell transplantation with fludarabine
and total body irradiation, followed by cyclosporine and mycophenolate mofetil,
followed by donor lymphocyte infusion.
- Determine the disease-free and overall survival of patients treated with this regimen.
- Determine the toxicity of this nonmyeloablative conditioning regimen in these patients.
OUTLINE: Patients receive a conditioning regimen comprising fludarabine IV on days -4 to -2
and total body irradiation on day 0. Allogeneic peripheral blood stem cells are infused on
Patients receive oral cyclosporine twice a day on days -3 to 35 and tapered until day 56 and
oral mycophenolate mofetil 3 times a day on days 0-40.
Patients with mixed chimerism and no graft-versus-host disease on day 56 receive donor
lymphocyte infusion (DLI) over 30 minutes on day 65 unless there is evidence of increasing
donor chimerism. DLI may be repeated every 65 days for up to 4 doses.
Patients are followed weekly for 3 months, monthly for 6 months, every 6 months through year
2, and then annually through year 5.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 4 years.
Masking: Open Label, Primary Purpose: Treatment
John A. Thompson, MD
Seattle Cancer Care Alliance
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|