Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005851
Status:
COMPLETED
Last Update Posted:
2019-07-24
First Post:
2000-06-02
Brief Title:
Low-Dose Total-Body Irradiation and Fludarabine Phosphate Followed By Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Stage IV Kidney Cancer
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Phase III Study of HLA-Matched Non-Myeloablative Peripheral Blood Mobilized Hematopoietic Progenitor Cell Transplantation as Treatment for Patients With Metastatic Renal Cell Carcinoma A Multi-Center Trial
Status:
COMPLETED
Status Verified Date:
2019-07
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:
The reason for doing this study is to see if cancer will respond to immune therapy after transplantation of blood stem cells from the bone marrow using a new kind of treatment regimen that is less toxic than that previously used for blood stem cell transplants This type of transplant uses much less chemotherapy and radiation than standard bone marrow transplants The treatment consists of medications that weaken the immune system so it doesnt reject the donors marrow cells Researchers hope that the immune cells from the donor will attack the tumor This is called a graft versus tumor effect and has been seen in other types of cancer In addition 65 days or more after the transplant the patient may be eligible for an immune treatment that uses additional immune cells from the donor to increase the effect of the stem cells against the cancer
Detailed Description:
PRIMARY OBJECTIVES
I To determine whether mixed or full donor hematopoietic chimerism can be safely established using a non-myeloablative conditioning regimen
II To determine whether mixed chimerism can be safely converted to full donor hematopoietic chimerism by infusions of donor lymphocytes DLI
III To evaluate potential efficacy of this approach as a treatment for metastatic renal cancer
OUTLINE
CONDITIONING REGIMEN Patients receive fludarabine phosphate intravenously IV on days -4 to -2 and undergo low-dose total-body irradiation TBI on day 0
TRANSPLANTATION Patients undergo allogeneic peripheral blood stem cell transplant on day 0
IMMUNOSUPRESSION Patients receive cyclosporine orally PO twice daily BID or IV once daily QD or BID on days -3 to 35 with taper to day 56 and mycophenolate mofetil PO or IV over 2 hours thrice daily TID on days 0-40
DLI Patients with stable mixed chimerism on day 56 with no evidence of graft-vs-host disease GVHD may receive escalating doses of non-mobilized DLI over 30 minutes Patients may receive up to 4 DLIs at escalating doses if there is disease progression with no evidence of GVHD
After completion of study treatment patients are followed up periodically for 5 years
I To determine whether mixed or full donor hematopoietic chimerism can be safely established using a non-myeloablative conditioning regimen
II To determine whether mixed chimerism can be safely converted to full donor hematopoietic chimerism by infusions of donor lymphocytes DLI
III To evaluate potential efficacy of this approach as a treatment for metastatic renal cancer
OUTLINE
CONDITIONING REGIMEN Patients receive fludarabine phosphate intravenously IV on days -4 to -2 and undergo low-dose total-body irradiation TBI on day 0
TRANSPLANTATION Patients undergo allogeneic peripheral blood stem cell transplant on day 0
IMMUNOSUPRESSION Patients receive cyclosporine orally PO twice daily BID or IV once daily QD or BID on days -3 to 35 with taper to day 56 and mycophenolate mofetil PO or IV over 2 hours thrice daily TID on days 0-40
DLI Patients with stable mixed chimerism on day 56 with no evidence of graft-vs-host disease GVHD may receive escalating doses of non-mobilized DLI over 30 minutes Patients may receive up to 4 DLIs at escalating doses if there is disease progression with no evidence of GVHD
After completion of study treatment patients are followed up periodically for 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| P30CA015704 | NIH | Fred Hutchinson Cancer Research CenterUniversity of Washington Cancer Consortium | httpsreporternihgovquickSearchP30CA015704 |
| NCI-2012-00581 | REGISTRY | None | None |
| 149500 | OTHER | None | None |