Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062140
Status:
COMPLETED
Last Update Posted:
2010-09-21
First Post:
2003-06-05
Brief Title:
Total-Body Irradiation Cyclophosphamide and Stem Cell Transplantation in Treating Patients With Hematologic Cancer
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Phase I Trial Of Total Body Irradiation Cyclophosphamide Dose-Adjustment Based On Its Metabolism And Hematopoietic Stem Cell Transplantation For Patients With Hematological Malignancy
Status:
COMPLETED
Status Verified Date:
2010-09
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 Adjusting the dose of drugs used in chemotherapy such as cyclophosphamide may decrease side effects while stopping cancer cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage cancer cells Stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill cancer cells
PURPOSE Phase I trial to study the effect on the body of dose-adjusted cyclophosphamide combined with total-body irradiation and donor stem cell transplantation in treating patients who have hematologic cancer
PURPOSE Phase I trial to study the effect on the body of dose-adjusted cyclophosphamide combined with total-body irradiation and donor stem cell transplantation in treating patients who have hematologic cancer
Detailed Description:
OBJECTIVES
Determine a safe and reproducible method of adjusting the dose of cyclophosphamide based on its metabolism when given in combination with total body irradiation and hematopoietic stem cell transplantation in patients with hematologic malignancy
OUTLINE
Preparative regimen Patients undergo total body irradiation twice daily on days -6 to -4 Patients then receive dose-adjusted based on metabolism cyclophosphamide IV over 1 hour on days -3 and -2
Hematopoietic stem cell HSC infusion Patients undergo allogeneic HSC transplantation on day 0
Patients receive graft-versus-host disease prophylaxis CNS prophylaxis and testicular irradiation as per institutional standard practices
Patients are followed daily until day 80 after transplantation and then regularly thereafter for survival
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
Determine a safe and reproducible method of adjusting the dose of cyclophosphamide based on its metabolism when given in combination with total body irradiation and hematopoietic stem cell transplantation in patients with hematologic malignancy
OUTLINE
Preparative regimen Patients undergo total body irradiation twice daily on days -6 to -4 Patients then receive dose-adjusted based on metabolism cyclophosphamide IV over 1 hour on days -3 and -2
Hematopoietic stem cell HSC infusion Patients undergo allogeneic HSC transplantation on day 0
Patients receive graft-versus-host disease prophylaxis CNS prophylaxis and testicular irradiation as per institutional standard practices
Patients are followed daily until day 80 after transplantation and then regularly thereafter for survival
PROJECTED ACCRUAL A total of 20 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 |
|---|---|---|---|
| FHCRC-179700 | None | None | None |
| CDR0000304522 | REGISTRY | PDQ | None |