Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020527
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2001-07-11
Brief Title:
Caspofungin Acetate in Treating Children With Fever and Neutropenia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Multicenter Open Non-Comparative Sequential Dose-Escalation Study to Investigate the Safety Tolerability and Pharmacokinetics of Two Separate Doses of MK-0991 in Children With New Onset Fever and Neutropenia
Status:
COMPLETED
Status Verified Date:
2003-03
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 Giving caspofungin acetate may be effective in preventing or controlling fever and neutropenia caused by chemotherapy or bone marrow transplantation
PURPOSE Clinical trial to study the effectiveness of caspofungin acetate in treating children who have fever and neutropenia caused by a weakened immune system
PURPOSE Clinical trial to study the effectiveness of caspofungin acetate in treating children who have fever and neutropenia caused by a weakened immune system
Detailed Description:
OBJECTIVES
Determine the pharmacokinetics and serum levels of caspofungin acetate in immunocompromised children with new-onset fever and neutropenia
Determine the safety and tolerability of this drug in this patient population
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to age 2 to 11 vs 12 to 17
Patients receive caspofungin acetate IV over 1 hour once daily for 4 to 28 days in the absence of the need to start standard empirical antifungal therapy a breakthrough fungal infection any deterioration of patient condition or unacceptable toxicity
Cohorts of 16 patients 8 per stratum receive caspofungin acetate at 1 of 2 dose levels Caspofungin acetate is escalated to dose level 2 if no more than 1 of 8 patients experiences dose-limiting toxicity at dose level 1
Patients are followed at 14 days
PROJECTED ACCRUAL A total of 32-64 patients 16 per dose level cohort 8 per stratum will be accrued for this study
Determine the pharmacokinetics and serum levels of caspofungin acetate in immunocompromised children with new-onset fever and neutropenia
Determine the safety and tolerability of this drug in this patient population
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to age 2 to 11 vs 12 to 17
Patients receive caspofungin acetate IV over 1 hour once daily for 4 to 28 days in the absence of the need to start standard empirical antifungal therapy a breakthrough fungal infection any deterioration of patient condition or unacceptable toxicity
Cohorts of 16 patients 8 per stratum receive caspofungin acetate at 1 of 2 dose levels Caspofungin acetate is escalated to dose level 2 if no more than 1 of 8 patients experiences dose-limiting toxicity at dose level 1
Patients are followed at 14 days
PROJECTED ACCRUAL A total of 32-64 patients 16 per dose level cohort 8 per stratum will be accrued for this study
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-01-C-0084C | None | None | None |