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| Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004230 |
Purpose
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.
| Condition | Intervention | Phase |
|
Cancer |
Drug: captopril Drug: cyclophosphamide Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy |
Phase III |
| Genetics Home Reference related topics: | breast cancer |
| MedlinePlus related topics: | Bone Marrow Transplantation Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma Multiple Myeloma |
| Drug Information available for: | Cyclophosphamide Captopril |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized |
| Official Title: | Phase III Study of Captopril in Patients Undergoing Autologous Bone Marrow/Stem Cell Transplantation |
| Estimated Enrollment: | 35 |
| Study Start Date: | October 1999 |
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
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Illinois | |||||
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |||||
| Chicago, Illinois, United States, 60611 | |||||
| Robert H. Lurie Cancer Center |
| National Cancer Institute (NCI) |
| Study Chair: | Leo I. Gordon, MD | Robert H. Lurie Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
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| Study ID Numbers: | CDR0000067472, NU-98CC1, NCI-G99-1658 |
| First Received: | January 28, 2000 |
| Last Updated: | November 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00004230 |
| Health Authority: | United States: Federal Government |
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