Overview

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

Status:
Completed
Trial end date:
2003-03-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fred Hutchinson Cancer Research Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Ribavirin
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