Submyeloablative Allogeneic Blood Stem Cell Transplantation With HLA Identical Donor Lymphocyte Infusions From Matched Related and Matched Unrelated Donors for Treatment of Metastatic Renal Cell Carcinoma
- Determine the feasibility of submyeloablative HLA-identical allogeneic peripheral blood
stem cell transplantation in patients with metastatic or recurrent renal cell
- Determine the toxicity of this regimen, in terms of incidence and severity of graft
rejection, acute graft-vs-host disease (GVHD), chronic GVHD, adverse effects from the
preparative regimen and thalidomide, and infection and bleeding, in these patients.
- Determine the efficacy of this regimen, in terms of objective partial and complete
response rates, in these patients.
- Determine the engraftment rates and extent of chimerism in patients treated with this
- Determine the overall survival and time to treatment failure rate in patients treated
with this regimen.
- Determine the impact of thalidomide on the treatment of chronic GVHD in patients
treated with this regimen.
OUTLINE: Patients are stratified according to risk (low vs high).
Patients receive fludarabine IV over 30 minutes once daily on days -4 to -2 followed by
total body irradiation on day -1. Patients receive tacrolimus IV over 24 hours or orally
daily on days -3 to 35 and oral mycophenolate mofetil twice daily on days -3 to 28 as
graft-vs-host disease (GVHD) prophylaxis. Patients undergo allogeneic peripheral blood stem
cell transplantation over 1-2 hours on day 0.
Patients maintaining a mixed chimerism with no evidence of grade III or IV GVHD receive
donor lymphocyte infusions (DLI) on days 60, 90, and 120. Patients may receive additional
DLI as needed. Patients with limited chronic GVHD receive oral thalidomide daily beginning
after day 80 and continuing for 1 year or until disease progression or resolution of chronic
Patients are followed at 1, 3, 6, and 12 months and then every 6 months thereafter.
PROJECTED ACCRUAL: A maximum of 20-40 patients (10-20 per stratum) will be accrued for this
Masking: Open Label, Primary Purpose: Treatment
Gary R. Hudes, MD
Fox Chase Cancer Center
United States: Federal Government
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|
|Fox Chase - Temple Cancer Center||Philadelphia, Pennsylvania 19111-2442|