Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003553
Status:
COMPLETED
Last Update Posted:
2020-06-19
First Post:
1999-11-01
Brief Title:
Peripheral Stem Cell Transplant in Treating Patients With Metastatic Kidney Cancer
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase II Study of HLA-Matched Peripheral Blood Mobilized Hematopoietic Progenitor Cell Transplantation for Metastatic Renal Cell Carcinoma Followed by Allogeneic T-Cell Infusion as Adoptive Immunotherapy
Status:
COMPLETED
Status Verified Date:
2020-06
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 Giving low doses of chemotherapy such as cyclophosphamide and fludarabine before a donor peripheral blood stem cell transplant helps stop the growth of tumor cells It may also stop the patients immune system from rejecting the donors stem cells The donated stem cells may replace the patients immune cells and help destroy any remaining tumor cells graft-versus-tumor effect Giving an infusion of the donors 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 bodys normal cells Giving cyclosporine with or without mycophenolate mofetil or methotrexate after the transplant may stop this from happening
PURPOSE This phase II trial is studying how well peripheral stem cell transplant works in treating patients with metastatic kidney cancer
PURPOSE This phase II trial is studying how well peripheral stem cell transplant works in treating patients with metastatic kidney cancer
Detailed Description:
OBJECTIVES
Determine the antitumor effect of allogeneic peripheral blood stem cell transplantation PBSCT in patients with metastatic renal cell carcinoma
Evaluate the safety and toxicity of a nonmyeloablative low-intensity preparative regimen followed by an HLA-matched allogeneic PBSCT in these patients
Determine engraftment by measuring donor-recipient chimerism in lymphoid and myeloid lineages in patients treated with this regimen
Determine the relationship between donor-host chimerism and the incidence of acute and chronic graft-versus-host disease in patients treated with this regimen
Determine the effect of lymphocyte infusions on donor-host chimerism in this patient population
Determine the response rate disease-free survival overall survival and mortality from the procedure or tumor progression in patients treated with this regimen
OUTLINE
Nonmyeloablative preparative regimen Patients receive 1 of 3 preparative regimens prior to peripheral blood progenitor cell PBPC transplantation Regimens 2 and 3 closed to accrual as of 10103
Regimen 1 Patients receive cyclophosphamide IV over 1 hour on days -7 and -6 and fludarabine IV over 30 minutes on days -5 to -1
Regimen 2 closed to accrual as of 10103 Patients receive cyclophosphamide IV over 1 hour on days -7 and -6 fludarabine IV over 30 minutes on days -5 to -1 and antithymocyte globulin on days -5 to -2
Regimen 3 closed to accrual as of 10103 Patients receive cyclophosphamide IV over 1 hour on days -8 to -6 fludarabine IV over 30 minutes on days -5 to -1 and antithymocyte globulin on days -5 to -2
PBPC transplantation Patients undergo mobilized CD34 PBPC transplantation on day 0 PBPC transplantation may be repeated on days 1 and 2 if deemed necessary
Graft-versus-host disease GVHD prophylaxis Patients receive 1 of 3 GVHD prophylaxis regimens
Regimen 1 closed to accrual as of 101700 Patients receive cyclosporine IV over 12 hours or orally beginning on day -4 and continuing for up to approximately 3 months
Regimen 2 open to accrual from 101700 through 21102 Patients receive cyclosporine as in regimen 1 Patients also receive mycophenolate mofetil
Regimen 3 open to accrual as of 21102 Patients receive cyclosporine as in regimen 1 Patients also receive methotrexate
Donor lymphocyte infusions Patients with progressive disease on days 15-30 day 60 or day 100 without GVHD receive infusions of donor lymphocytes Further donor lymphocyte infusions after day 100 may be given at the discretion of the attending physician
Patients are followed every 2 months for 6 months every 3 months for 2 years and then every 6 months for 2½ years
PROJECTED ACCRUAL A total of 80 patients will be accrued for this study
Determine the antitumor effect of allogeneic peripheral blood stem cell transplantation PBSCT in patients with metastatic renal cell carcinoma
Evaluate the safety and toxicity of a nonmyeloablative low-intensity preparative regimen followed by an HLA-matched allogeneic PBSCT in these patients
Determine engraftment by measuring donor-recipient chimerism in lymphoid and myeloid lineages in patients treated with this regimen
Determine the relationship between donor-host chimerism and the incidence of acute and chronic graft-versus-host disease in patients treated with this regimen
Determine the effect of lymphocyte infusions on donor-host chimerism in this patient population
Determine the response rate disease-free survival overall survival and mortality from the procedure or tumor progression in patients treated with this regimen
OUTLINE
Nonmyeloablative preparative regimen Patients receive 1 of 3 preparative regimens prior to peripheral blood progenitor cell PBPC transplantation Regimens 2 and 3 closed to accrual as of 10103
Regimen 1 Patients receive cyclophosphamide IV over 1 hour on days -7 and -6 and fludarabine IV over 30 minutes on days -5 to -1
Regimen 2 closed to accrual as of 10103 Patients receive cyclophosphamide IV over 1 hour on days -7 and -6 fludarabine IV over 30 minutes on days -5 to -1 and antithymocyte globulin on days -5 to -2
Regimen 3 closed to accrual as of 10103 Patients receive cyclophosphamide IV over 1 hour on days -8 to -6 fludarabine IV over 30 minutes on days -5 to -1 and antithymocyte globulin on days -5 to -2
PBPC transplantation Patients undergo mobilized CD34 PBPC transplantation on day 0 PBPC transplantation may be repeated on days 1 and 2 if deemed necessary
Graft-versus-host disease GVHD prophylaxis Patients receive 1 of 3 GVHD prophylaxis regimens
Regimen 1 closed to accrual as of 101700 Patients receive cyclosporine IV over 12 hours or orally beginning on day -4 and continuing for up to approximately 3 months
Regimen 2 open to accrual from 101700 through 21102 Patients receive cyclosporine as in regimen 1 Patients also receive mycophenolate mofetil
Regimen 3 open to accrual as of 21102 Patients receive cyclosporine as in regimen 1 Patients also receive methotrexate
Donor lymphocyte infusions Patients with progressive disease on days 15-30 day 60 or day 100 without GVHD receive infusions of donor lymphocytes Further donor lymphocyte infusions after day 100 may be given at the discretion of the attending physician
Patients are followed every 2 months for 6 months every 3 months for 2 years and then every 6 months for 2½ years
PROJECTED ACCRUAL A total of 80 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000066610 | OTHER | NIH | None |
| NHLBI-97-H-0196 | None | None | None |