Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00262886
Status:
COMPLETED
Last Update Posted:
2013-06-06
First Post:
2005-12-06
Brief Title:
Donor Peripheral Stem Cell or Bone Marrow Transplant in Treating Patients With Relapsed or Refractory Metastatic Kidney Cancer
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Non-Myeloablative HLA-Matched Sibling Allogeneic Peripheral Blood Stem Cell Transplantation for Metastatic Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE A peripheral stem cell transplant or bone marrow transplant from a brother or sister may be an effective treatment for kidney cancer
PURPOSE This phase II trial is studying how well a donor peripheral stem cell or bone marrow transplant works in treating patients with relapsed or refractory metastatic kidney cancer
PURPOSE This phase II trial is studying how well a donor peripheral stem cell or bone marrow transplant works in treating patients with relapsed or refractory metastatic kidney cancer
Detailed Description:
OBJECTIVES
Determine the efficacy of nonmyeloablative sibling allogeneic peripheral blood stem cell transplantation in patients with relapsed or refractory metastatic renal cell carcinoma
Determine the toxic effects of this regimen in these patients
OUTLINE This is a pilot study
Conditioning regimen Patients receive cyclophosphamide IV on days -7 and -6 and fludarabine IV on days -5 to -1 Patients receiving 56-mismatched cells also receive anti-thymocyte globulin IV on days -5 to -3
Allogeneic peripheral blood stem cell PBSC infusion Patients undergo allogeneic PBSC or bone marrow transplantation on day 0
Graft-versus-host disease GVHD prophylaxis Patients receive oral mycophenolate mofetil twice daily on days 0-30 Patients receive tacrolimus IV continuously or orally twice daily beginning on day -2 and continuing up to day 44-100 in the absence of GVHD
Donor lymphocyte infusion Patients with partial or complete T-cell chimerism receive up to 3 donor lymphocyte infusions in the absence of GVHD or progressive disease
After completion of study treatment patients are evaluated periodically for 3 years
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study
Determine the efficacy of nonmyeloablative sibling allogeneic peripheral blood stem cell transplantation in patients with relapsed or refractory metastatic renal cell carcinoma
Determine the toxic effects of this regimen in these patients
OUTLINE This is a pilot study
Conditioning regimen Patients receive cyclophosphamide IV on days -7 and -6 and fludarabine IV on days -5 to -1 Patients receiving 56-mismatched cells also receive anti-thymocyte globulin IV on days -5 to -3
Allogeneic peripheral blood stem cell PBSC infusion Patients undergo allogeneic PBSC or bone marrow transplantation on day 0
Graft-versus-host disease GVHD prophylaxis Patients receive oral mycophenolate mofetil twice daily on days 0-30 Patients receive tacrolimus IV continuously or orally twice daily beginning on day -2 and continuing up to day 44-100 in the absence of GVHD
Donor lymphocyte infusion Patients with partial or complete T-cell chimerism receive up to 3 donor lymphocyte infusions in the absence of GVHD or progressive disease
After completion of study treatment patients are evaluated periodically for 3 years
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| URCC-RSRB-09084 | None | None | None |
| URCC-U1801 | None | None | None |