Anidulafungin in Treating Immunocompromised Children With Neutropenia

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Drug: anidulafungin


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Neutropenia due to cytotoxic chemotherapy or aplastic anemia Duration expected to be 10 days Absolute neutrophil count less than 500/mm^3 OR less than 1,000/mm^3 and expected to fall below 500/mm^3 within 72 hours No deeply invasive fungal infection confirmed prior to study entry 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 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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: anidulafungin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infection, neutropenia, unspecified childhood solid tumor, protocol specific