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Phase III Randomized Study of Captopril in Patients Undergoing Autologous Bone Marrow or Stem Cell Transplantation

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Captopril in Treating Patients Undergoing Bone Marrow or Stem Cell Transplantation

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase III

Supportive care, Treatment

Closed

Not specified

NCI

NU-98CC1
NCI-G99-1658, NCT00004230

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.

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

Expected Enrollment

A total of 35 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Leo Gordon, MD, Protocol chair
Ph: 312-695-4546
Email: l-gordon@northwestern.edu

Registry Information

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

Trial Start Date		1999-10-28

Registered in ClinicalTrials.gov		NCT00004230

Date Submitted to PDQ		1999-12-13

Information Last Verified		2007-07-11

NCI Grant/Contract Number		P30-CA60553

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.