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
- 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.
Primary Purpose: Supportive Care
Thomas J. Walsh, MD
National Cancer Institute (NCI)
United States: Federal Government
|Lombardi Cancer Center||Washington, District of Columbia 20007|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|Children's National Medical Center||Washington, District of Columbia 20010-2970|
|St. Jude Children's Research Hospital||Memphis, Tennessee 38105-2794|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|