Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Recurrent Kidney Cancer
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill cancer cells. Sometimes the transplanted cells can be rejected by the body's tissues. Mycophenolate mofetil, tacrolimus, and donor white blood cells may prevent this from happening.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation in treating patients who have metastatic or recurrent kidney cancer.
|Kidney Cancer||Biological: therapeutic allogeneic lymphocytes Drug: fludarabine phosphate Drug: mycophenolate mofetil Drug: tacrolimus Drug: thalidomide Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy||Phase 2|
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
|Study Start Date:||June 2001|
|Study Completion Date:||October 2006|
|Primary Completion Date:||October 2006 (Final data collection date for primary outcome measure)|
- Determine the feasibility of submyeloablative HLA-identical allogeneic peripheral blood stem cell transplantation in patients with metastatic or recurrent renal cell carcinoma.
- 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 regimen.
- 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 GVHD.
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 study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00025519
|Study Chair:||Gary R. Hudes, MD||Fox Chase Cancer Center|