Phase III Study of Captopril in Patients Undergoing Autologous Bone Marrow/Stem Cell Transplantation
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.
Allocation: Randomized, Primary Purpose: Supportive Care
Leo I. Gordon, MD
Robert H. Lurie Cancer Center
United States: Federal Government
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University||Chicago, Illinois 60611|