Adoptive Immunotherapy by Allogeneic Stem Cell Transplantation for Metastatic Renal Cell Carcinoma: A Phase II Study
- Determine the overall response rate and overall and disease-free survival of patients
with unresectable or metastatic renal cell cancer treated with fludarabine and
cyclophosphamide followed by allogeneic peripheral blood stem cell transplantation.
- Determine the toxicity and treatment-related mortality of this regimen in these
- Determine the percentage of donor chimerism in patients treated with this regimen.
OUTLINE: Patients receive fludarabine IV over 30 minutes on days -7 to -3 and
cyclophosphamide IV over 1-2 hours on days -4 and -3. Allogeneic peripheral blood stem cells
are infused on day 0. Patients then receive filgrastim (G-CSF) subcutaneously daily
beginning on day 5 and continuing until blood counts recover.
Patients receive graft-versus-host disease (GVHD) prophylaxis comprising oral tacrolimus
twice daily on days -1 to 90 and methotrexate IV on days 1, 3, and 6.
After day 120, patients with persistent disease and no signs of active GVHD may receive
donor lymphocyte infusion (DLI). DLI may be repeated every 8 weeks for a total of 2
Patients are followed every 2 months for 1 year and then every 6 months for 4 years OR every
2 months for 6 months and then every 6 months for 4.5 years if patient receives DLI.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 18-24
Primary Purpose: Treatment
Brian I. Rini, MD
University of California, San Francisco
United States: Federal Government
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|Indiana University Cancer Center||Indianapolis, Indiana 46202-5265|
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|CCOP - Northern New Jersey||Hackensack, New Jersey 07601|
|CCOP - Oklahoma||Tulsa, Oklahoma 74136|
|CCOP - Mayo Clinic Scottsdale Oncology Program||Scottsdale, Arizona 85259|