Captopril in Treating Patients Undergoing Bone Marrow or Stem Cell Transplantation
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| ClinicalTrials.gov Identifier: NCT00004230 |
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Recruitment Status :
Completed
First Posted : May 3, 2004
Last Update Posted : June 6, 2012
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Cancer | Drug: captopril Drug: cyclophosphamide Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 35 participants |
| Allocation: | Randomized |
| Primary Purpose: | Supportive Care |
| Official Title: | Phase III Study of Captopril in Patients Undergoing Autologous Bone Marrow/Stem Cell Transplantation |
| Study Start Date : | October 1999 |
| Actual Primary Completion Date : | March 2002 |
| Actual Study Completion Date : | March 2002 |
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004230
| United States, Illinois | |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| Study Chair: | Leo I. Gordon, MD | Robert H. Lurie Cancer Center |
| Responsible Party: | Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00004230 History of Changes |
| Other Study ID Numbers: |
NU 98CC1 NU-98CC1 NCI-G99-1658 |
| First Posted: | May 3, 2004 Key Record Dates |
| Last Update Posted: | June 6, 2012 |
| Last Verified: | May 2012 |
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pulmonary complications stage IV breast cancer stage IIIA breast cancer stage IIIB breast cancer recurrent childhood acute lymphoblastic leukemia recurrent adult Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma refractory multiple myeloma recurrent childhood rhabdomyosarcoma stage II ovarian epithelial cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer recurrent ovarian epithelial cancer disseminated neuroblastoma recurrent neuroblastoma |
recurrent Wilms tumor and other childhood kidney tumors stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma recurrent childhood lymphoblastic lymphoma stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia recurrent childhood acute myeloid leukemia recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia relapsing chronic myelogenous leukemia refractory chronic lymphocytic leukemia stage III malignant testicular germ cell tumor recurrent malignant testicular germ cell tumor chronic phase chronic myelogenous leukemia |
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Cyclophosphamide Captopril Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors Antihypertensive Agents |