Captopril in Treating Patients Undergoing Bone Marrow or Stem Cell Transplantation
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.
|Cancer||Drug: captopril Drug: cyclophosphamide Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy||Phase 3|
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|Official Title:||Phase III Study of Captopril in Patients Undergoing Autologous Bone Marrow/Stem Cell Transplantation|
|Study Start Date:||October 1999|
|Study Completion Date:||March 2002|
|Primary Completion Date:||March 2002 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004230
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University|
|Chicago, Illinois, United States, 60611|
|Study Chair:||Leo I. Gordon, MD||Robert H. Lurie Cancer Center|