Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00295997
Status:
UNKNOWN
Last Update Posted:
2014-01-06
First Post:
2006-02-23
Brief Title:
Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer Metastatic Kidney Cancer or Aplastic Anemia
Sponsor:
University of California San Francisco
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Non-myeloablative Allogeneic Stem Cell Transplantation With Match Unrelated Donors for Treatment of Hematologic Malignancies and Renal Cell Carcinoma and Aplastic Anemia
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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 before a donor stem cell transplant using stem cells that closely match the patients stem cells helps stop the growth of cancer cells It also stops the patients immune system from rejecting the donors stem cells The donated stem cells may replace the patients immune system and help destroy any remaining cancer 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 antithymocyte globulin before transplant and cyclosporine and mycophenolate mofetil after transplant may stop this from happening
PURPOSE This clinical trial is studying how well a donor stem cell transplant works in treating patients with hematologic cancer metastatic kidney cancer or aplastic anemia
PURPOSE This clinical trial is studying how well a donor stem cell transplant works in treating patients with hematologic cancer metastatic kidney cancer or aplastic anemia
Detailed Description:
OBJECTIVES
Primary
Determine the treatment-related mortality TRM rate at 100 days in patients with hematologic malignancy metastatic renal cell carcinoma or aplastic anemia undergoing nonmyeloablative allogeneic stem cell transplantation using matched unrelated donors
Secondary
Determine the TRM at 12 months in patients treated with this regimen
Determine the 6-month engraftment rate in patients treated with this regimen
Determine 1-year overall survival of patients treated with this regimen
OUTLINE
Nonmyeloablative preparative regimen Patients receive fludarabine IV over 30 minutes on days -7 to -3 busulfan IV over 6 hours on days -4 and -3 and anti-thymocyte globulin IV over 6-10 hours on days -4 to -1
NOTE Patients with aplastic anemia receive cyclophosphamide IV over 2 hours on days -6 to -3 instead of busulfan
Allogeneic stem cell reinfusion Patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0 Patients then receive filgrastim G-CSF subcutaneously daily beginning on day 7 and continuing until blood counts recover
Graft-vs-host disease GVHD prophylaxis Patients receive tacrolimus orally twice daily or IV continuously beginning on day -2 and continuing for approximately for 6-12 months after transplantation Patients also receive mycophenolate mofetil orally or IV twice daily on days 0 to 60 and methotrexate IV on days 1 3 6 and 11
NOTE Patients with aplastic anemia receive methotrexate IV on days 1 3 and 6 not day 11
Donor lymphocyte infusion DLI After day 180 patients with no evidence of active GVHD may receive DLI A second DLI may be infused 8 weeks after the first in the absence of disease response or GVHD
After completion of study treatment patients are followed periodically for at least 2 years
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study
Primary
Determine the treatment-related mortality TRM rate at 100 days in patients with hematologic malignancy metastatic renal cell carcinoma or aplastic anemia undergoing nonmyeloablative allogeneic stem cell transplantation using matched unrelated donors
Secondary
Determine the TRM at 12 months in patients treated with this regimen
Determine the 6-month engraftment rate in patients treated with this regimen
Determine 1-year overall survival of patients treated with this regimen
OUTLINE
Nonmyeloablative preparative regimen Patients receive fludarabine IV over 30 minutes on days -7 to -3 busulfan IV over 6 hours on days -4 and -3 and anti-thymocyte globulin IV over 6-10 hours on days -4 to -1
NOTE Patients with aplastic anemia receive cyclophosphamide IV over 2 hours on days -6 to -3 instead of busulfan
Allogeneic stem cell reinfusion Patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0 Patients then receive filgrastim G-CSF subcutaneously daily beginning on day 7 and continuing until blood counts recover
Graft-vs-host disease GVHD prophylaxis Patients receive tacrolimus orally twice daily or IV continuously beginning on day -2 and continuing for approximately for 6-12 months after transplantation Patients also receive mycophenolate mofetil orally or IV twice daily on days 0 to 60 and methotrexate IV on days 1 3 6 and 11
NOTE Patients with aplastic anemia receive methotrexate IV on days 1 3 and 6 not day 11
Donor lymphocyte infusion DLI After day 180 patients with no evidence of active GVHD may receive DLI A second DLI may be infused 8 weeks after the first in the absence of disease response or GVHD
After completion of study treatment patients are followed periodically for at least 2 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 |
|---|---|---|---|
| UCSF-2101 | None | None | None |
| UCSF-01251 | None | None | None |
| UCSF-H5010-19585-05 | None | None | None |