Clinical Trials Directory

Trials / Completed

CompletedNCT00078858

Mycophenolate Mofetil and Cyclosporine in Reducing Graft-Versus-Host Disease in Patients With Hematologic Malignancies or Metastatic Kidney Cancer Undergoing Donor Stem Cell Transplant

Prolonged Mycophenolate Mofetil and Truncated Cyclosporine Postgrafting Immunosuppression to Reduce Life-Threatening GVHD After Unrelated Donor Peripheral Blood Cell Transplantation Using Nonmyeloablative Conditioning for Patients With Hematologic Malignancies and Renal Cell Carcinoma - A Multi-Center Trial

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
37 (actual)
Sponsor
Fred Hutchinson Cancer Center · Academic / Other
Sex
All
Age
—
Healthy volunteers
Not accepted

Summary

This phase I/II trial studies whether stopping cyclosporine before mycophenolate mofetil is better at reducing the risk of life-threatening graft-versus-host disease (GVHD) than the previous approach where mycophenolate mofetil was stopped before cyclosporine. The other reason this study is being done because at the present time there are no curative therapies known outside of stem cell transplantation for these types of cancer. Because of age or underlying health status, patients may have a higher likelihood of experiencing harm from a conventional blood stem cell transplant. This study tests whether this new blood stem cell transplant method can be made safer by changing the order and length of time that immune suppressing drugs are given after transplant.

Detailed description

PRIMARY OBJECTIVES: I. To determine whether the incidence of life-threatening GVHD can be reduced after unrelated donor peripheral blood mononuclear cell (PBMC) hematopoietic cell transplantation (HCT) using nonmyeloablative conditioning with earlier discontinuation of cyclosporine (CSP) and extended administration of mycophenolate mofetil (MMF) in patients with hematologic malignancies and metastatic renal cell carcinoma. SECONDARY OBJECTIVES: I. To compare the incidence of acute and chronic GVHD to protocols 1463 and 1641. II. To compare the utilization of corticosteroids to protocols 1463 and 1641. III. To compare survival to that achieved under protocol 1463 and 1641. OUTLINE: CONDITIONING: Patients receive fludarabine phosphate intravenously (IV) over 30 minutes on days -4 to -2, and undergo total-body irradiation (TBI) on day 0. TRANSPLANTATION: Patients undergo allogeneic PBMC transplant on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine orally (PO) twice daily (BID) on days -3 to 80 with taper to day 150 and mycophenolate mofetil PO or IV thrice daily (TID) on days 0-30, BID on days 31-150, and then taper to day 180. Treatment continues in the absence of unacceptable toxicity. After completion of study treatment, patients are followed up periodically for 24 months and then yearly for 5 years.

Conditions

Interventions

TypeNameDescription
DRUGfludarabine phosphateGiven IV
RADIATIONtotal-body irradiationUndergo TBI
PROCEDUREnonmyeloablative allogeneic hematopoietic stem cell transplantationUndergo allogeneic PBMC transplantation
PROCEDUREperipheral blood stem cell transplantationUndergo allogeneic PBMC transplantation
DRUGcyclosporineGiven PO
DRUGmycophenolate mofetilGiven PO or IV
OTHERlaboratory biomarker analysisCorrelative studies

Timeline

Start date
2003-09-01
Primary completion
2006-01-01
First posted
2004-03-09
Last updated
2020-01-18

Locations

10 sites across 3 countries: United States, Germany, Italy

Source: ClinicalTrials.gov record NCT00078858. Inclusion in this directory is not an endorsement.