Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00365287
Status:
COMPLETED
Last Update Posted:
2017-11-29
First Post:
2006-08-16
Brief Title:
Combination Chemotherapy and Total-Body Irradiation Before Donor Umbilical Cord Blood Transplant in Treating Patients With Advanced Hematologic Cancer Metastatic Breast Cancer or Kidney Cancer
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
Transplantation of Umbilical Cord Blood From Unrelated Donors in Patients With Hematological Diseases Using a Non-Myeloablative Preparative Regimen
Status:
COMPLETED
Status Verified Date:
2017-11
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 and radiation therapy before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer cells It also stops the patients immune system from rejecting the donors stem cells when they do not exactly match the patients blood 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 antithymocyte globulin before transplant and cyclosporine and mycophenolate mofetil after transplant may stop this from happening
PURPOSE This phase III trial is studying the side effects of giving combination chemotherapy together with total-body irradiation before donor umbilical cord blood transplant and to see how well they work in treating patients with advanced hematologic cancer metastatic breast cancer or kidney cancer
PURPOSE This phase III trial is studying the side effects of giving combination chemotherapy together with total-body irradiation before donor umbilical cord blood transplant and to see how well they work in treating patients with advanced hematologic cancer metastatic breast cancer or kidney cancer
Detailed Description:
OBJECTIVES
Primary
Determine the safety of nonmyeloablative preparative regimen comprising cyclophosphamide fludarabine and total-body irradiation with or without anti-thymocyte globulin in terms of non-relapse mortality at day 100 post-transplantation in patients with advanced hematologic malignancies metastatic breast cancer or renal cell cancer who are undergoing umbilical cord blood transplantation from an unrelated donor
Secondary
Determine the hematopoietic recovery and degree of chimerism on days 21 60 100 180 and 360 post-transplantation
Determine the incidence of grade II-IV and III-IV acute graft-versus-host disease GVHD by day 100 post-transplantation and chronic GVHD at 1 year post-transplantation
Evaluate the risk of relapse at 1 year post-transplantation
Determine overall survival at 1 year post-transplantation
OUTLINE
Nonmyeloablative preparative regimen Patients receive cyclophosphamide IV over 2 hours on day -6 and fludarabine IV over 1 hour on days -6 to -2 Patients also undergo total-body irradiation on day -1 Some patients may also receive anti-thymocyte globulin ATG IV twice daily on days -6 to -4
NOTE Patients who have not had prior combination chemotherapy within the past 3 months OR who only received 1 prior induction course for the treatment of acute lymphoblastic leukemia acute myeloid leukemia myelodysplastic syndromes or chronic myelogenous leukemia in blast crisis receive ATG during the preparative regimen
Umbilical cord blood transplantation UCBT Patients undergo UCBT from an unrelated donor on day 0
Graft-versus-host disease prophylaxis Patients receive cyclosporine IV over 2 hours or orally 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180 Patients also receive mycophenolate mofetil IV or orally twice daily beginning on day -3 and continuing until day 30 or until 7 days after engraftment
After transplantation patients are followed periodically for 2 years
PROJECTED ACCRUAL A total of 120 patients will be accrued for this study
Primary
Determine the safety of nonmyeloablative preparative regimen comprising cyclophosphamide fludarabine and total-body irradiation with or without anti-thymocyte globulin in terms of non-relapse mortality at day 100 post-transplantation in patients with advanced hematologic malignancies metastatic breast cancer or renal cell cancer who are undergoing umbilical cord blood transplantation from an unrelated donor
Secondary
Determine the hematopoietic recovery and degree of chimerism on days 21 60 100 180 and 360 post-transplantation
Determine the incidence of grade II-IV and III-IV acute graft-versus-host disease GVHD by day 100 post-transplantation and chronic GVHD at 1 year post-transplantation
Evaluate the risk of relapse at 1 year post-transplantation
Determine overall survival at 1 year post-transplantation
OUTLINE
Nonmyeloablative preparative regimen Patients receive cyclophosphamide IV over 2 hours on day -6 and fludarabine IV over 1 hour on days -6 to -2 Patients also undergo total-body irradiation on day -1 Some patients may also receive anti-thymocyte globulin ATG IV twice daily on days -6 to -4
NOTE Patients who have not had prior combination chemotherapy within the past 3 months OR who only received 1 prior induction course for the treatment of acute lymphoblastic leukemia acute myeloid leukemia myelodysplastic syndromes or chronic myelogenous leukemia in blast crisis receive ATG during the preparative regimen
Umbilical cord blood transplantation UCBT Patients undergo UCBT from an unrelated donor on day 0
Graft-versus-host disease prophylaxis Patients receive cyclosporine IV over 2 hours or orally 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180 Patients also receive mycophenolate mofetil IV or orally twice daily beginning on day -3 and continuing until day 30 or until 7 days after engraftment
After transplantation patients are followed periodically for 2 years
PROJECTED ACCRUAL A total of 120 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 |
|---|---|---|---|
| MT2000-15 | OTHER | Blood and Marrow Transplantation Program | None |