Captopril in Treating Patients Undergoing Bone Marrow or Stem Cell Transplantation
Information source: Northwestern University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cancer
Intervention: captopril (Drug); cyclophosphamide (Drug); autologous bone marrow transplantation (Procedure); peripheral blood stem cell transplantation (Procedure); radiation therapy (Radiation)
Phase: Phase 3
Status: Completed
Sponsored by: Northwestern University Official(s) and/or principal investigator(s): Leo I. Gordon, MD, Study Chair, Affiliation: Robert H. Lurie Cancer Center
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.
Clinical Details
Official title: Phase III Study of Captopril in Patients Undergoing Autologous Bone Marrow/Stem Cell Transplantation
Study design: Allocation: Randomized, Primary Purpose: Supportive Care
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS: Eligible for existing autologous bone marrow or stem cell
transplantation protocols using either a high dose chemotherapy regimen or a
cyclophosphamide and total body radiotherapy regimen
PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not
specified Other: No other concurrent medical illness that would preclude study
PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior captopril or other ACE
inhibitors
Locations and Contacts
Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois 60611, United States
Additional Information
Starting date: October 1999
Last updated: May 31, 2012
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