Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Cancer Institute (NCI)
OBJECTIVES: * Determine the pharmacokinetics of voriconazole administered IV and orally for the prevention of systemic fungal infection in pediatric patients with neutropenia after chemotherapy. * 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 day 9. 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.
Age
2–11
Sex
ALL
Healthy volunteers
Not accepted