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Anidulafungin in Treating Immunocompromised Children With Neutropenia

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00068471
First received: September 10, 2003
Last updated: June 18, 2013
Last verified: April 2004
  Purpose

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 Intervention Phase
Infection
Neutropenia
Unspecified Childhood Solid Tumor, Protocol Specific
Drug: anidulafungin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: July 2003
Study Completion Date: October 2007
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.

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00068471

Locations
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010-2970
Lombardi Cancer Center at Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
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
Investigators
Principal Investigator: Thomas J. Walsh, MD National Cancer Institute (NCI)
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00068471     History of Changes
Obsolete Identifiers: NCT00063466
Other Study ID Numbers: CDR0000322888, NCI-03-C-0229C
Study First Received: September 10, 2003
Last Updated: June 18, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Infection
Neutropenia
Agranulocytosis
Hematologic Diseases
Leukocyte Disorders
Leukopenia
Anidulafungin
Echinocandins
Anti-Infective Agents
Antifungal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014