Chemotherapy, Radiation Therapy, Peripheral Stem Cell Transplantation, and Immunosuppressive Therapy in Treating Patients With Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells are rejected by the body's normal tissues. Immunosuppressive drugs such as mycophenolate mofetil and cyclosporine may be an effective treatment to prevent rejection.
PURPOSE: Phase I/II trial to study the effectiveness of combining chemotherapy, radiation therapy, and peripheral stem cell transplantation followed by immunosuppressive therapy in treating patients who have cancer.
Biological: therapeutic allogeneic lymphocytes
Drug: fludarabine phosphate
Drug: mycophenolate mofetil
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Induction of Mixed Hematopoietic Chimerism in Patients Using Fludarabine, Low Dose TBI, PBSC Infusion and Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil|
|Study Start Date:||May 2000|
|Study Completion Date:||September 2005|
|Primary Completion Date:||September 2005 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the risk of graft rejection associated with the addition of fludarabine to a nonmyeloablative conditioning regimen in patients with malignancies treatable by allogeneic bone marrow (stem cell) transplantation. II. Compare the rate of graft rejection in patients treated with this regimen vs patients previously untreated with fludarabine. III. Determine the rate of acute grade II/IV graft versus host disease (GVHD) and chronic GVHD in these patients treated with fludarabine, low dose total body irradiation, and allogeneic peripheral blood stem cell transplantation followed by immunosuppression with cyclosporine and mycophenolate mofetil.
OUTLINE: This is a multicenter study. Patients receive fludarabine IV on days -4 to -2, and total body irradiation followed by filgrastim (G-CSF) mobilized allogeneic peripheral blood stem cell transplantation on day 0. Patients also receive oral cyclosporine twice daily on days -3 to 56 and oral mycophenolate mofetil twice daily on days 0 to 27. Following completion of immunosuppression therapy patients with stable mixed chimerism and no evidence of graft versus host disease (GVHD) receive donor lymphocytes IV over 30 minutes on or after day 65. Treatment repeats every 65 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed weekly until day 90 after last lymphocyte infusion, at 4, 6, 12, 18, and 24 months, and then annually thereafter.
PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 2 years.
|United States, California|
|Beckman Research Institute, City of Hope|
|Los Angeles, California, United States, 91010|
|Stanford, California, United States, 94305|
|United States, Colorado|
|University of Colorado Cancer Center|
|Denver, Colorado, United States, 80262|
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109|
|Universitaet Leipzig - Chirurgische Klinik und Poliklinik I|
|Leipzig, Germany, D-04103|
|University of Torino|
|Torino, Italy, 10126|
|Study Chair:||David G. Maloney, MD, PhD||Fred Hutchinson Cancer Research Center|