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Captopril in Treating Patients Undergoing Bone Marrow or Stem Cell Transplantation



Captopril in Treating Patients Undergoing Bone Marrow or Stem Cell Transplantation

For Condition: Leukemia,Lymphoma,Multiple Myeloma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Robert H. Lurie Cancer Center
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type:  Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: /
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY 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 --Prior/Concurrent Therapy-- - See Disease Characteristics - No prior captopril or other ACE inhibitors --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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
LeoGordon,  Study Chair,  Robert H. Lurie Cancer Center

Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago,  Illinois,  60611
United States
 


Additional Information:
Study ID Numbers:  CDR0000067472;  NU-98CC1,NCI-G99-1658
Study Start Date: October 1999
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004230

Other Multiple Myeloma Studies:
1. Combination Chemotherapy in Treating Patients With Advanced Cancer

2. Total-Body Irradiation With Or Without Fludarabine Followed By Allogeneic Hematopoietic Stem Cell Transplantation in Treating Patients With Hematologic Malignancies

3. Itraconazole Compared With Fluconazole to Prevent Infections in Patients Undergoing Peripheral Stem Cell or Bone Marrow Transplantation

4. Flavopiridol in Treating Patients With Refractory Cancer

5. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Advanced Hematologic Cancer

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Captopril in Treating Patients Undergoing Bone Marrow or Stem Cell Transplantation
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