Clinical Trial: Ribavirin Compared With Standard Care in Treating Patients With Respiratory Syncytial Virus Following Stem Cell Transplantation

This study is no longer recruiting patients.

Sponsors and Collaborators: Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Antivirals such as ribavirin are used to treat infections caused by viruses. It is not yet known if ribavirin is more effective than standard therapy in preventing pneumonia in patients who have respiratory syncytial virus (RSV) infection following stem cell transplantation.

PURPOSE: Randomized phase III trial to compare the effectiveness of ribavirin with that of standard therapy in preventing pneumonia in patients who have RSV infection following stem cell transplantation.

Condition Treatment or Intervention Phase
Infection
 Drug: ribavirin
 Procedure: complications of therapy assessment/management
 Procedure: infection prophylaxis/management
 Procedure: supportive care/therapy
Phase III

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of Aerosolized Ribavirin Versus Standard Supportive Therapy in Patients With Respiratory Syncytial Virus Following Stem Cell Transplantation

Further Study Details: 

OBJECTIVES:

OUTLINE: This is a randomized, investigator-blind, controlled, multicenter study. Patients are stratified according to engraftment status (pre vs post) and transplant type (HLA matched-related allogeneic, syngeneic, or autologous vs HLA mismatched-related or unrelated allogeneic). Patients are randomized to one of two treatment arms.

Patients are followed at days 14 and 28.

PROJECTED ACCRUAL: A total of 90 patients (45 per arm) will be accrued for this study.

Eligibility

Ages Eligible for Study:  2 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS: Age:

  • 2 and over

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Pulmonary:

  • Oxygen saturation 92-100% by pulse oximeter
  • Normal respiratory rate for age

Other:

  • No prior adverse reactions to ribavirin
  • No clinical status that would preclude study
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy:

  • See Disease Characteristics
  • No prior immunotherapy for RSV
  • No prior or concurrent RSV hyperimmune globulin or monoclonal antibodies

Chemotherapy:

  • Not specified

Endocrine therapy:

  • See Disease Characteristics

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • No prior antiviral drugs with anti-RSV activity
  • Bronchodilator treatment allowed for patients with asthma or a history of reactive airway disease and/or who develop bronchospasm
  • Concurrent ganciclovir, foscarnet, or IV immunoglobulin allowed
  • No mechanical ventilation
  • No other concurrent anti-viral drugs with anti-RSV activity

Location Information


Alabama
      University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham,  Alabama,  35233,  United States

Illinois
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States

Missouri
      Siteman Cancer Center, Saint Louis,  Missouri,  63110,  United States

Washington
      Fred Hutchinson Cancer Research Center, Seattle,  Washington,  98109-1024,  United States

Study chairs or principal investigators

Michael Boeckh, MD,  Study Chair,  Fred Hutchinson Cancer Research Center   

More Information

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

Study ID Numbers:  CDR0000068593; FHCRC-1290.00; NCI-G01-1939
Record last reviewed:  October 2003
Last Updated:  October 13, 2004
Record first received:  May 6, 2001
ClinicalTrials.gov Identifier:  NCT00016081
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005