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A Randomized Phase III Study To Evaluate The Safety And Efficacy Or Ribavirin Inhaled Solution In Preventing Progression Of Upper Respiratory Tract Respiratory Syncytial Virus (RSV) Infection To RSV Pneumonia In Blood And Bone Marrow Transplant (BMT) Recipients


Phase 3
2 Years
N/A
Not Enrolling
Both
Infection

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Trial Information

A Randomized Phase III Study To Evaluate The Safety And Efficacy Or Ribavirin Inhaled Solution In Preventing Progression Of Upper Respiratory Tract Respiratory Syncytial Virus (RSV) Infection To RSV Pneumonia In Blood And Bone Marrow Transplant (BMT) Recipients


OBJECTIVES:

- Compare the efficacy of aerosolized ribavirin vs standard supportive therapy, in terms
of preventing progression of upper respiratory tract respiratory syncytial virus (RSV)
infection to pneumonia, in patients with RSV following stem cell transplantation.

- Determine the safety of aerosolized ribavirin in this patient population.

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.

- Arm I: Patients receive standard supportive care for immunocompromised patients with
upper respiratory tract infections. Patient also receive aerosolized ribavirin by face
mask, mist, or oxygen tent over 2 hours 3 times daily on days 1-10.

- Arm II: Patients receive standard supportive care as in arm I. Treatment continues in
the absence of progression to pneumonia or unacceptable toxicity.

Patients are followed at days 14 and 28.

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

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Confirmed upper respiratory tract respiratory syncytial virus (RSV) infection
documented in nasopharyngeal-throat specimen by rapid antigen test (ELISA), IFA, or
shell vial)

- Signs or symptoms of upper respiratory tract infection (e.g., rhinorrhea and/or
low-grade fever (under 101 degrees F with or without evidence of a sore throat)

- Received prior stem cell transplantation (SCT) and meet one of the following
criteria:

- Between start of conditioning (preparative) regimen and day 90 after allogeneic,
autologous, or syngeneic SCT

- Between days 91 and 180 after unrelated or HLA mismatch-related allogeneic SCT

- Between days 91 and 180 after SCT with graft-versus-host disease requiring
systemic steroids expected to continue throughout study

- No radiographic evidence of pneumonia

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Principal Investigator

Michael Boeckh, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

1290.00

NCT ID:

NCT00016081

Start Date:

March 1998

Completion Date:

March 2003

Related Keywords:

  • Infection
  • infection

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Siteman Cancer CenterSaint Louis, Missouri  63110