Captopril in Treating Patients Undergoing Bone Marrow or Stem Cell Transplantation
NCT ID: NCT00004230
Last Updated: 2012-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
35 participants
INTERVENTIONAL
1999-10-31
2002-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SUPPORTIVE_CARE
Interventions
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captopril
cyclophosphamide
autologous bone marrow transplantation
peripheral blood stem cell transplantation
radiation therapy
Eligibility Criteria
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Inclusion Criteria
PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior captopril or other ACE inhibitors
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Northwestern University
OTHER
Responsible Party
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Principal Investigators
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Leo I. Gordon, MD
Role: STUDY_CHAIR
Robert H. Lurie Cancer Center
Locations
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Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States
Countries
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Other Identifiers
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NU-98CC1
Identifier Type: -
Identifier Source: secondary_id
NCI-G99-1658
Identifier Type: -
Identifier Source: secondary_id
NU 98CC1
Identifier Type: -
Identifier Source: org_study_id
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