NCT00068471

Anidulafungin in Treating Immunocompromised Children With Neutropenia

Phase I-II Study of the Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children With Neutropenia

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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.

Conditions

• Infection
• Neutropenia
• Unspecified Childhood Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	anidulafungin

Timeline

• Start date: 2003-07-01
• Completion: 2007-10-01
• First posted: 2003-09-11
• Last updated: 2013-06-19

Locations

5 sites across 1 country: United States