Clinical Trials Directory

Trials / Completed

CompletedNCT00020527

Caspofungin Acetate in Treating Children With Fever and Neutropenia

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
Phase
N/A
Study type
Interventional
Enrollment
—
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
2 Years – 17 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
DRUGcaspofungin acetate

Timeline

Start date
2001-03-01
Completion
2003-06-01
First posted
2003-01-27
Last updated
2013-06-19

Locations

5 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00020527. Inclusion in this directory is not an endorsement.