Official Title: “Phase III Study of Captopril in Patients Undergoing Autologous Bone Marrow/Stem Cell Transplantation”

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.

Study Type: Interventional

Study Design: Supportive Care, Randomized

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.

Intervention(s) in this Clinical Trial

• Drug: captopril
• Drug: cyclophosphamide
• Procedure: autologous bone marrow transplantation
• Procedure: peripheral blood stem cell transplantation
• Procedure: radiation therapy

• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Robert H. Lurie Cancer Center

Overall Clinical Trial Officials and Contacts

Leo I. Gordon, MD Study Chair Robert H. Lurie Cancer Center  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00004230

Study ID Number: CDR0000067472

ClinicalTrials.gov Identifier: NCT00004230

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database