Clinical Trials Directory

Trials / Completed

CompletedNCT00005799

Fludarabine Phosphate, Low-Dose Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies or Kidney Cancer

Low-Dose TBI and Fludarabine Followed by Unrelated Donor Stem Cell Transplantation for Patients With Hematologic Malignancies and Renal Cell Carcinoma - A Multi-center Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
55 (actual)
Sponsor
Fred Hutchinson Cancer Center · Academic / Other
Sex
All
Age
—
Healthy volunteers
Not accepted

Summary

This clinical trial studies fludarabine phosphate, low-dose total body irradiation, and donor stem cell transplant in treating patients with hematologic malignancies or kidney cancer. Giving chemotherapy drugs, such as fludarabine phosphate, and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine before the transplant and cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.

Detailed description

PRIMARY OBJECTIVES: I. To determine whether stable allogeneic engraftment from unrelated hematopoietic stem cell donors can be safely established using a non-myeloablative conditioning regimen in patients with hematologic malignancies and renal cell carcinoma. SECONDARY OBJECTIVES: I. To evaluate whether donor lymphocyte infusion (DLI) can be safely used in patients with mixed or full donor chimerism to eliminate persistent or progressive disease. OUTLINE: CONDITIONING REGIMEN: Patients receive fludarabine phosphate intravenously (IV) on days -4 to -2. Patients also undergo low-dose total-body irradiation (TBI) on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) or bone marrow transplantation on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine orally (PO) twice daily (BID) on days -3 to 100 with taper to day 177 and mycophenolate mofetil PO BID on days 0-40 with taper to day 96. Patients with mixed chimerism, persistent or progressive disease, and no evidence of graft-versus-host disease and who have been off immunosuppression for at least 2 weeks undergo DLI over 30 minutes. DLI may be repeated every 65 days for up to 3 doses. After completion of study treatment, patients are follow-up periodically for 5 years.

Conditions

Interventions

TypeNameDescription
DRUGfludarabine phosphateGiven IV
RADIATIONtotal-body irradiationUndergo low-dose TBI
PROCEDUREnonmyeloablative allogeneic hematopoietic stem cell transplantationUndergo nonmyeloablative HSCT
PROCEDUREallogeneic bone marrow transplantationUndergo nonmyeloablative allogeneic bone marrow transplantation
PROCEDUREperipheral blood stem cell transplantationUndergo nonmyeloablative allogeneic PBSC transplantation
BIOLOGICALtherapeutic allogeneic lymphocytesUndergo DLI
DRUGcyclosporineGiven PO
DRUGmycophenolate mofetilGiven PO
OTHERpharmacological studyCorrelative studies
OTHERlaboratory biomarker analysisCorrelative studies

Timeline

Start date
1999-11-01
Primary completion
2002-07-01
First posted
2004-04-02
Last updated
2019-09-10

Locations

7 sites across 2 countries: United States, Germany

Source: ClinicalTrials.gov record NCT00005799. Inclusion in this directory is not an endorsement.