Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Anidulafungin in Treating Immunocompromised Children With Neutropenia

Basic Trial Information

Objectives

1. Determine the safety, tolerability, and pharmacokinetics of anidulafungin in immunocompromised children with neutropenia.
2. Determine the frequency of deeply invasive fungal infections in children receiving this drug for early empirical therapy.

Entry Criteria

Disease Characteristics:

• Neutropenia due to cytotoxic chemotherapy or aplastic anemia
  • Duration expected to be 10 days
  • Absolute neutrophil count less than 500/mm³ OR less than 1,000/mm³ and expected to fall below 500/mm³ within 72 hours
• No deeply invasive fungal infection confirmed prior to study entry

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• More than 4 weeks since prior investigational drugs
• No prior participation in this clinical trial
• No prior anidulafungin
• No other concurrent investigational drugs
• No other concurrent systemic antifungal agents (e.g., amphotericin, systemic azoles, or triazole antifungal agents)
  • Concurrent oral, nonabsorbable azoles and topical antifungal agents (e.g., nystatin and/or azole formulations) allowed
• Concurrent broad-spectrum antibiotics allowed

Patient Characteristics:

Age

• 2 to 17

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• See Disease Characteristics

Hepatic

• AST or ALT no greater than 5 times upper limit of normal (ULN)
• Bilirubin no greater than 2.5 times ULN

Renal

• Creatinine clearance at least 30 mL/min

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier contraception during and for at least 30 days after study participation
• No prior anaphylaxis attributed to the echinocandin class of antifungals
• No other concurrent medical condition that would preclude study participation

Expected Enrollment

A total of 25 patients (approximately 12 per group) were accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Thomas Walsh, MD, Principal investigator		Ph: 301-402-0023

Registry Information
Official Title		Phase I-II Study of the Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children with Neutropenia
Trial Start Date		2003-07-01
Registered in ClinicalTrials.gov		NCT00068471
Date Submitted to PDQ		2003-07-01
Information Last Verified		2004-04-06

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