Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066599
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2003-08-06
Brief Title:
Voriconazole in Preventing Fungal Infections in Children With Neutropenia After Chemotherapy
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2004-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 2APatients 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
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 2APatients 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-03-C-0218 | None | None | None |