Phase I/II Study of HLA-Matched Non-Myeloablative Peripheral Blood Mobilized Hematopoietic Progenitor Cell Transplantation as Treatment for Patients With Metastatic Renal Cell Carcinoma. A Multi-Center Trial.
I. To determine whether mixed or full donor hematopoietic chimerism can be safely
established using a non-myeloablative conditioning regimen.
II. To determine whether mixed chimerism can be safely converted to full donor hematopoietic
chimerism by infusions of donor lymphocytes (DLI).
III. To evaluate potential efficacy of this approach as a treatment for metastatic renal
CONDITIONING REGIMEN: Patients receive fludarabine phosphate intravenously (IV) on days -4
to -2 and undergo low-dose total body irradiation (TBI) on day 0.
TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplant on day 0.
IMMUNOSUPRESSION: Patients receive cyclosporine orally (PO) twice daily (BID) or IV once
daily (QD) or BID on days -3 to 35 with taper to day 56, and mycophenolate mofetil PO or IV
over 2 hours thrice daily (TID) on days 0-40.
DLI: Patients with stable mixed chimerism on day 56 with no evidence of graft-vs-host
disease (GVHD) may receive escalating doses of non-mobilized DLI over 30 minutes. Patients
may receive up to 4 DLIs at escalating doses if there is disease progression with no
evidence of GVHD.
After completion of study treatment, patients are followed up periodically for 5 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
True response rate (complete response [CR] or partial response [PR]) greater than the 15% achievable with standard therapy
If 6 or more out of 25 patients achieve a CR or PR, then we will be at least 80% confident that the true response rate exceeds 15% and that this approach is potentially efficacious.
Up to 5 years
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|
|Rocky Mountain Cancer Center||Denver, Colorado 80218|
|Baylor University Medical Center||Dallas, Texas 75246|
|VA Puget Sound Health Care System||Seattle, Washington 98101|
|University of Arizona Health Sciences Center||Tucson, Arizona 85724|
|Froedtert Memorial Lutheran Hospital, Medical College of Wisconsin||Milwaukee, Wisconsin 53226|