An Open-Label, Intravenous To Oral Switch, Multiple Dose, Multi-Center Study To Investigate The Pharmacokinetics, Safety And Tolerability Of Voriconazole In Hospitalized Children Aged 2 - <12 Years Who Require Treatment For The Prevention Of Systemic Fungal Infection
- Determine the pharmacokinetics of voriconazole administered IV and orally for the
prevention of systemic fungal infection in pediatric patients with neutropenia after
- Determine the safety and tolerability of this drug in these patients.
OUTLINE: This is a pilot, open-label, multicenter study. Patients are stratified according
to age (2 to 5 vs 6 to 11).
Within 48 hours after completion of chemotherapy, patients begin prophylactic therapy:
- Cohort 1 (the first 18 patients, 9 per stratum): Patients receive voriconazole IV over
80-160 minutes twice daily on days 1-8 and oral voriconazole* twice daily beginning on
Depending on the results of the interim pharmacokinetic analysis, the last 18 patients
entered on the study receive 1 of the following regimens:
- Cohort 2A:Patients receive voriconazole as in cohort 1 at a higher dose.
- Cohort 2B: Patients receive voriconazole IV over 80-160 minutes twice daily on days 1-4
and oral voriconazole* twice daily beginning on day 5.
NOTE: *Patients who are unable to tolerate oral medication may continue receiving IV
medication until day 20.
In all cohorts, treatment continues until blood counts recover or day 30 in the absence of
unacceptable toxicity or progression of infection.
Patients are followed at 30 days and at 12 months.
PROJECTED ACCRUAL: A total of 49 patients (approximately 24 per stratum) were accrued for
this study within 1 year.
Masking: Open Label, Primary Purpose: Supportive Care
Thomas J. Walsh, MD
National Cancer Institute (NCI)
United States: Federal Government
|Children's Hospital of Philadelphia||Philadelphia, Pennsylvania 19104|
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|
|Ireland Cancer Center||Cleveland, Ohio 44106-5065|
|Children's Hospital of Orange County||Orange, California 92668|
|Children's Hospital and Health Center, San Diego||San Diego, California 92123-4282|
|Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas||Dallas, Texas 75390-9063|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|