Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00242931
Status:
WITHDRAWN
Last Update Posted:
2012-06-01
First Post:
2005-10-20
Brief Title:
FluTBI in Treating Patients Not Responding to Previous Hormone Therapy
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
Pilot Trial of Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for the Treatment of Patients With Hormone-Refractory Prostate Cancer
Status:
WITHDRAWN
Status Verified Date:
2010-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to successfully recruit subjects to this study
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 fludarabine and radiation therapy before a donor stem cell transplant 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 Sometimes the transplanted cells from a donor can also make an immune response against the bodys normal cells Giving cyclosporine and mycophenolate mofetil after transplant may stop this from happening
PURPOSE This phase II trial is studying how well giving fludarabine together with total-body irradiation works in treating patients who are undergoing a donor stem cell transplant for progressive metastatic prostate cancer that has not responded to previous hormone therapy
PURPOSE This phase II trial is studying how well giving fludarabine together with total-body irradiation works in treating patients who are undergoing a donor stem cell transplant for progressive metastatic prostate cancer that has not responded to previous hormone therapy
Detailed Description:
OBJECTIVES
Determine the treatment-related mortality in patients with hormone-refractory progressive metastatic prostate cancer treated with nonmyeloablative conditioning comprising fludarabine and total-body irradiation followed by allogeneic hematopoietic stem cell transplantation
OUTLINE
Nonmyeloablative conditioning regimen Patients receive fludarabine IV on days -4 to -2 and total-body irradiation TBI on day 0
Allogeneic hematopoietic stem cell transplantation AHSCT After TBI patients undergo AHSCT on day 0
Immunosuppression Patients receive oral cyclosporine twice daily on days -3 to 56 followed by a taper until day 81 Patients also receive oral mycophenolate mofetil twice daily on days 0-27 if patient has a related donor OR three times daily on days 0-29 and then twice daily on days 30-149 followed by additional tapering until day 180 if patient has an unrelated donor
PROJECTED ACCRUAL A total of 10 patients will be accrued for this study
Determine the treatment-related mortality in patients with hormone-refractory progressive metastatic prostate cancer treated with nonmyeloablative conditioning comprising fludarabine and total-body irradiation followed by allogeneic hematopoietic stem cell transplantation
OUTLINE
Nonmyeloablative conditioning regimen Patients receive fludarabine IV on days -4 to -2 and total-body irradiation TBI on day 0
Allogeneic hematopoietic stem cell transplantation AHSCT After TBI patients undergo AHSCT on day 0
Immunosuppression Patients receive oral cyclosporine twice daily on days -3 to 56 followed by a taper until day 81 Patients also receive oral mycophenolate mofetil twice daily on days 0-27 if patient has a related donor OR three times daily on days 0-29 and then twice daily on days 30-149 followed by additional tapering until day 180 if patient has an unrelated donor
PROJECTED ACCRUAL A total of 10 patients will be accrued for this study
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 |
|---|---|---|---|
| OHSU-SOL-04109-L | OTHER | None | None |
| OHSU-373 | OTHER | OHSU | None |