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Phase III Randomized Study of Aerosolized Ribavirin Versus Standard Supportive Therapy in Patients With Respiratory Syncytial Virus Following Stem Cell Transplantation
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outline Trial Contact Information Registry Information
Alternate Title
Ribavirin Compared With Standard Care in Treating Patients With Respiratory Syncytial Virus Following Stem Cell Transplantation
Basic Trial Information
Phase | Type | Status | Age | Protocol IDs |
---|
Phase III | Supportive care | Closed | 2 and over | FHCRC-1290.00 NCI-G01-1939, NCT00016081 |
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.
Entry 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
Prior/Concurrent Therapy:
Biologic therapy: - See Disease Characteristics
- No prior immunotherapy for RSV
- No prior or concurrent RSV hyperimmune globulin or monoclonal
antibodies
Chemotherapy: Endocrine therapy: - See Disease Characteristics
Radiotherapy: Surgery: 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
Patient Characteristics:
Age: Performance status: Life expectancy: Hematopoietic: Hepatic: Renal: 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
Expected Enrollment A total of 90 patients (45 per arm) will be accrued for this study. 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.
Trial Contact Information
Trial Lead Organizations Fred Hutchinson Cancer Research Center | | | Michael Boeckh, MD, Protocol chair | | | |
Registry Information | | Official Title | | 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 | | Trial Start Date | | 1998-03-13 | | Registered in ClinicalTrials.gov | | NCT00016081 | | Date Submitted to PDQ | | 2001-03-12 | | Information Last Verified | | 2003-09-04 | | NCI Grant/Contract Number | | AI65306, CA15704 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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