Lymphoma Clinical Trial
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
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.
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.
;
Primary Purpose: Supportive Care
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