Voriconazole in Preventing Fungal Infections in Children With Neutropenia After Chemotherapy
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.
|Kidney Cancer Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Neuroblastoma Neutropenia Sarcoma||Drug: voriconazole||Phase 2|
|Study Design:||Masking: None (Open Label)
Primary Purpose: Supportive Care
|Official Title:||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|
|Study Start Date:||June 2003|
|Study Completion Date:||June 2004|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00066599
|United States, California|
|Children's Hospital of Orange County|
|Orange, California, United States, 92868|
|Children's Hospital and Health Center, San Diego|
|San Diego, California, United States, 92123-4282|
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Ireland Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104-4318|
|United States, Texas|
|Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Thomas J. Walsh, MD||National Cancer Institute (NCI)|