Trials / Completed

CompletedNCT00066599

Voriconazole in Preventing Fungal Infections in Children With Neutropenia After Chemotherapy

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

Status: Completed
Phase: Phase 2
Study type: Interventional
Enrollment: —

Sponsor: National Cancer Institute (NCI) · NIH
Sex: All
Age: 2 Years – 11 Years
Healthy volunteers: Not accepted

Summary

RATIONALE: Voriconazole may be effective in preventing systemic fungal infections following chemotherapy. PURPOSE: Phase II trial to study the effectiveness of voriconazole in preventing systemic fungal infections in children who have neutropenia after receiving chemotherapy for leukemia, lymphoma, or aplastic anemia or in preparation for bone marrow or stem cell transplantation.

Detailed description

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.

Conditions

Interventions

Type	Name	Description
DRUG	voriconazole

Timeline

Start date: 2003-06-01
Completion: 2004-06-01
First posted: 2003-08-07
Last updated: 2013-06-19

Locations

7 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00066599. Inclusion in this directory is not an endorsement.