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

Alternate Title

Ribavirin With or Without Monoclonal Antibody Therapy in Treating Patients Who Develop RSV Pneumonia Following Peripheral Stem Cell Transplantation

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care Closed Any age NCI FHCRC-1379.00 NCI-G01-1929, NCT00014391

Objectives

I. Compare the efficacy, in terms of all-cause mortality reduction, of 
ribavirin with or without palivizumab in patients with respiratory syncytial 
virus pneumonia following stem cell transplantation.

II. Determine the safety of these treatments in this patient population.

Entry Criteria

Disease Characteristics:

Confirmed respiratory syncytial virus (RSV) pneumonia documented by rapid
antigen test (ELISA or IFA), shell vial culture of bronchoalveolar lavage
specimens, or tissue antigen staining of lung biopsy sample
 New infiltrate on chest x-ray and at least one of the following:
  Cough
  Wheezing
  Dyspnea and/or tachypnea (greater than 150% of baseline)
  Oxygen saturation less than 90% on two occasions 1 hour apart on room air
  Arterial oxygen pressure less than 80

No more than 60 hours since confirmation of pneumonia by chest x-ray

Received prior stem cell transplantation and meet one of the following:
 Between start of conditioning (preparative) regimen and day 90 after
 allogeneic, autologous, or syngeneic stem cell transplantation (SCT)
 Between days 91 and 180 after unrelated HLA mismatch-related allogeneic SCT
  (bone marrow, peripheral blood stem cells (PBSC), or cord blood), T-cell
  depleted allogeneic transplantation, or CD34 selected allogeneic PBSC
  transplantation
 Between days 91 and 180 after SCT with graft-versus-host disease requiring
  systemic steroids expected to continue throughout study

Other pulmonary pathogens in addition to RSV allowed

Prior/Concurrent Therapy:

Biologic therapy:
 See Disease Characteristics
 At least 3 months since prior immunotherapy for respiratory syncytial virus
  (RSV) including RSV hyperimmune globulin or other RSV monoclonal antibodies
 Concurrent IV immunoglobulin allowed
 No prior experimental RSV vaccine
 No concurrent RSV hyperimmune globulin
 No other concurrent RSV-specific monoclonal antibodies
 
Chemotherapy:
 Not specified

Endocrine therapy:
 See Disease Characteristics

Radiotherapy:
 Not specified

Surgery:
 Not specified

Other:
 At least 4 weeks since prior investigational products for respiratory viral
  diseases
 At least 3 months since prior anti-viral drugs with specific anti-RSV
  activity
 Prior aerosolized ribavirin allowed
 No other concurrent anti-viral drugs with specific anti-RSV activity
 Concurrent ganciclovir or foscarnet allowed
 Ventilator support allowed

Patient Characteristics:

Age:
 Any age

Performance status:
 Not specified

Life expectancy:
 At least 48 hours

Hematopoietic:
 Not specified

Hepatic:
 Not specified

Renal:
 Not specified

Other:
 No prior adverse reaction to ribavirin or palivizumab
 No allergy to monoclonal antibodies
 HIV negative
 Not pregnant or nursing
 Negative pregnancy test
 Fertile patients must use effective contraception during and for 3 months
  after study

Expected Enrollment

A total of 140 patients (70 per arm) will be accrued for this study within 2 
years.

Outline

This is a randomized, double-blind, placebo-controlled, multicenter study.  
Patients are stratified according to prior ribavirin exposure for this 
infection (24 hours or more vs less than 24 hours) and requirement for 
ventilator support (yes vs no).  Patients are randomized to one of two 
treatment arms.

Arm I: Patients receive aerosolized ribavirin via face mask or oxygen tent 
over 2 hours 3 times daily or over 16-18 hours on days 1-10 and palivizumab IV 
2 hours before ribavirin administration on day 1.

Arm II: Patients receive aerosolized ribavirin as in arm I and placebo IV 2 
hours before ribavirin administration on day 1.

Patients are followed at 14, 21, and 28 days.

Trial Contact Information

Trial Lead Organizations

Fred Hutchinson Cancer Research Center

Michael Boeckh, MD, Protocol chair		Ph: 206-667-4898

Registry Information
Official Title		A Randomized Double-Blind Placebo-Controlled Phase III Study To Evaluate The Safety And Efficacy Of Palivizumab Combined With Aerosolized Ribavirin Compared To Ribavirin Alone To Treat RSV Pneumonia In Patients With Bone Marrow Transplants (BMT)
Trial Start Date		1999-02-01
Registered in ClinicalTrials.gov		NCT00014391
Date Submitted to PDQ		2001-02-16
Information Last Verified		2007-07-11
NCI Grant/Contract Number		N01-A165306, P30-CA15704