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NCT00004230 Clinical Trial

Captopril in Treating Patients Undergoing Bone Marrow or Stem Cell Transplantation

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00004230
Other study ID # NU 98CC1
Secondary ID NU-98CC1NCI-G99-
Status Completed
Phase Phase 3
First received January 28, 2000
Last updated May 31, 2012
Start date October 1999
Est. completion date March 2002

Study information
Verified date May 2012
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date March 2002
Est. primary completion date March 2002
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Allocation: Randomized, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Drug:
• captopril

• cyclophosphamide

Procedure:
• autologous bone marrow transplantation

• peripheral blood stem cell transplantation

Radiation:
• radiation therapy

Locations
Country Name City State
United States Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago Illinois

Sponsors (2)
Lead Sponsor Collaborator
Northwestern University National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

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