Anidulafungin in Treating Immunocompromised Children With Neutropenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00068471
Recruitment Status : Completed
First Posted : September 11, 2003
Last Update Posted : June 19, 2013
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Infection Neutropenia Unspecified Childhood Solid Tumor, Protocol Specific Drug: anidulafungin Phase 1 Phase 2

Detailed Description:


  • 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 Type : Interventional  (Clinical Trial)
Masking: None (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
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 2 to 17

Performance status

  • Not specified

Life expectancy

  • Not specified


  • See Disease Characteristics


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


  • Creatinine clearance at least 30 mL/min


  • 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


Biologic therapy

  • Not specified


  • See Disease Characteristics

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Thomas J. Walsh, MD National Cancer Institute (NCI) Identifier: NCT00068471     History of Changes
Obsolete Identifiers: NCT00063466
Other Study ID Numbers: CDR0000322888
First Posted: September 11, 2003    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: April 2004

Keywords provided by National Cancer Institute (NCI):
unspecified childhood solid tumor, protocol specific

Additional relevant MeSH terms:
Leukocyte Disorders
Hematologic Diseases
Antifungal Agents
Anti-Infective Agents