Anidulafungin in Treating Immunocompromised Children With Neutropenia

Phase 1

Completed

• Conditions: Infection; Neutropenia; Unspecified Childhood Solid Tumor, Protocol Specific

• Registration Number: NCT00068471
• Lead Sponsor: National Cancer Institute (NCI)

Brief 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.

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2003-09-10
• Study First Submitted QC: 2003-09-10
• Study First Posted: 2003-09-11
• Status Verified: 2004-04
• Study Completion: 2007-10
• Last Update Submitted: 2013-06-18
• Last Update Posted: 2013-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (5)

Duke Comprehensive Cancer Center; 🇺🇸 Durham, North Carolina, United States

Lombardi Cancer Center at Georgetown University Medical Center; 🇺🇸 Washington, District of Columbia, United States

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support; 🇺🇸 Bethesda, Maryland, United States

St. Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States

Children's National Medical Center; 🇺🇸 Washington, District of Columbia, United States