Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00357396
Status:
COMPLETED
Last Update Posted:
2015-11-25
First Post:
2006-07-26
Brief Title:
Busulfan Melphalan and Thiotepa Followed By a Donor Stem Cell Transplant in Treating Patients With High-Risk Ewings Tumors
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase II Trial of a Chemotherapy Based Regimen of Intravenous Busulfan Busulfex Melphalan and Thiotepa as Myeloablative Regimen Followed by a T- Cell Depleted Allogeneic Hematopoietic Stem Cell Transplant From and HLA-Compatible Donor in the Treatment of High Risk Ewings Sarcoma Family Tumors
Status:
COMPLETED
Status Verified Date:
2015-10
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 chemotherapy drugs such as busulfan melphalan and thiotepa before a donor stem cell transplant helps stop the growth of tumor cells and prepares the patients bone marrow for the stem cells When the healthy stem cells from a donor are infused into the patient they may help the patients bone marrow make stem cells red blood cells white blood cells and platelets Sometimes the transplanted cells from a donor can make an immune response against the bodys normal tissues Giving tacrolimus sirolimus and mycophenolate mofetil may stop this from happening
PURPOSE This phase II trial is studying how well giving busulfan together with melphalan and thiotepa followed by a donor stem cell transplant works in treating patients with high-risk Ewings tumors
PURPOSE This phase II trial is studying how well giving busulfan together with melphalan and thiotepa followed by a donor stem cell transplant works in treating patients with high-risk Ewings tumors
Detailed Description:
OBJECTIVES
Evaluate disease-free and overall survival of patients with high-risk tumors of the Ewings family treated with unmodified T-cell depleted allogeneic hematopoietic stem cell transplantation after cytoreduction comprising busulfan melphalan and thiotepa
Determine the regimen-related morbidity and mortality in these patients
Determine the incidence of acute and chronic graft-vs-host disease in patients treated with this regimen
Determine the biologic response of minimal residual disease in patients treated with this regimen
OUTLINE This is a prospective study
Myeloablative preparative regimen Patients receive busulfan IV over 2 hours every 6 hours on days -8 to -6 melphalan IV over 20 minutes on days -5 to -3 and thiotepa IV over 4 hours on day -2
Allogeneic hematopoietic stem cell transplant Patients undergo allogeneic bone marrow or T-cell depleted peripheral blood stem cell transplantation on day 0
Graft-vs-host disease GVHD prophylaxis Patients receive treatment according to institutional guidelines and are given treatment against infection
After completion of study treatment patients are followed periodically for at least 3 years
Evaluate disease-free and overall survival of patients with high-risk tumors of the Ewings family treated with unmodified T-cell depleted allogeneic hematopoietic stem cell transplantation after cytoreduction comprising busulfan melphalan and thiotepa
Determine the regimen-related morbidity and mortality in these patients
Determine the incidence of acute and chronic graft-vs-host disease in patients treated with this regimen
Determine the biologic response of minimal residual disease in patients treated with this regimen
OUTLINE This is a prospective study
Myeloablative preparative regimen Patients receive busulfan IV over 2 hours every 6 hours on days -8 to -6 melphalan IV over 20 minutes on days -5 to -3 and thiotepa IV over 4 hours on day -2
Allogeneic hematopoietic stem cell transplant Patients undergo allogeneic bone marrow or T-cell depleted peripheral blood stem cell transplantation on day 0
Graft-vs-host disease GVHD prophylaxis Patients receive treatment according to institutional guidelines and are given treatment against infection
After completion of study treatment patients are followed periodically for at least 3 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 |
|---|---|---|---|
| MSKCC-05059 | None | None | None |