Anidulafungin in Treating Immunocompromised Children With Neutropenia
RATIONALE: Anidulafungin may be effective in preventing fungal infections in immunocompromised children who have neutropenia.
PURPOSE: This phase I/II trial is studying the side effects of anidulafungin and to see how well it works in preventing fungal infections in immunocompromised children with neutropenia caused by chemotherapy or aplastic anemia.
|Infection Neutropenia Unspecified Childhood Solid Tumor, Protocol Specific||Drug: anidulafungin||Phase 1 Phase 2|
|Study Design:||Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Phase I-II Study of the Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children With Neutropenia|
|Study Start Date:||July 2003|
|Study Completion Date:||October 2007|
- Determine the safety, tolerability, and pharmacokinetics of anidulafungin in immunocompromised children with neutropenia.
- Determine the frequency of deeply invasive fungal infections in children receiving this drug for early empirical therapy.
OUTLINE: This is a dose-escalation, open-label, multicenter study. Patients are assigned to 1 of 2 groups according to age (2 to 11 years vs 12 to 17 years).
Patients receive anidulafungin IV once daily over 45-120 minutes. In both groups, cohorts of 6 patients receive escalating doses of anidulafungin. Treatment continues for up to 28 days or until patients recover from neutropenia or become eligible for standard empirical antifungal therapy in the absence of unacceptable toxicity or breakthrough fungal infection.
Patients are followed at 7-9 days.
PROJECTED ACCRUAL: A total of 25 patients (approximately 12 per group) were accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00068471
|United States, District of Columbia|
|Lombardi Cancer Center at Georgetown University Medical Center|
|Washington, District of Columbia, United States, 20007|
|Children's National Medical Center|
|Washington, District of Columbia, United States, 20010-2970|
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|United States, Tennessee|
|St. Jude Children's Research Hospital|
|Memphis, Tennessee, United States, 38105-2794|
|Principal Investigator:||Thomas J. Walsh, MD||National Cancer Institute (NCI)|