Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004230
Status:
COMPLETED
Last Update Posted:
2012-06-06
First Post:
2000-01-28
Brief Title:
Captopril in Treating Patients Undergoing Bone Marrow or Stem Cell Transplantation
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Phase III Study of Captopril in Patients Undergoing Autologous Bone MarrowStem Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2012-05
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 Captopril may protect the lungs from the side effects of bone marrow or stem cell transplantation
PURPOSE Randomized phase III trial to determine the effectiveness of captopril to lessen the side effects in patients who are undergoing bone marrow or stem cell transplantation following chemotherapy and radiation therapy
PURPOSE Randomized phase III trial to determine the effectiveness of captopril to lessen the side effects in patients who are undergoing bone marrow or stem cell transplantation following chemotherapy and radiation therapy
Detailed Description:
OBJECTIVES I Determine if captopril can block or prevent lung injury in patients undergoing autologous bone marrow or stem cell transplantation following cyclophosphamide and total body radiotherapy or high dose chemotherapy II Determine a series of surrogate lung injury prediction markers for monitoring patients undergoing therapy
OUTLINE This is a randomized study Patients are stratified according to preparative regimen high dose chemotherapy versus cyclophosphamide and total body radiotherapy Patients are randomized into one of two treatment arms All patients undergo a conditioning regimen consisting of cyclophosphamide daily on days -6 and -5 and total body radiotherapy on day -4 through -1 or high dose chemotherapy per transplantation protocol Arm I Patients receive oral captopril 2 to 3 times daily beginning on the first day of the conditioning regimen and continuing until day 100 post autologous bone marrow or stem cell transplantation Arm II Patients receive no captopril while undergoing conditioning therapy Patients are followed at 6 months
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study
OUTLINE This is a randomized study Patients are stratified according to preparative regimen high dose chemotherapy versus cyclophosphamide and total body radiotherapy Patients are randomized into one of two treatment arms All patients undergo a conditioning regimen consisting of cyclophosphamide daily on days -6 and -5 and total body radiotherapy on day -4 through -1 or high dose chemotherapy per transplantation protocol Arm I Patients receive oral captopril 2 to 3 times daily beginning on the first day of the conditioning regimen and continuing until day 100 post autologous bone marrow or stem cell transplantation Arm II Patients receive no captopril while undergoing conditioning therapy Patients are followed at 6 months
PROJECTED ACCRUAL A total of 35 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 |
|---|---|---|---|
| NCI-G99-1658 | None | None | None |
| NU-98CC1 | None | None | None |