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Anidulafungin in Treating Immunocompromised Children With Neutropenia

Primary Purpose

Infection, Neutropenia, Unspecified Childhood Solid Tumor, Protocol Specific

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
anidulafungin
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infection focused on measuring infection, neutropenia, unspecified childhood solid tumor, protocol specific

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lombardi Cancer Center at Georgetown University Medical Center
  • Children's National Medical Center
  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
  • Duke Comprehensive Cancer Center
  • St. Jude Children's Research Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 10, 2003
Last Updated
June 18, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00068471
Brief Title
Anidulafungin in Treating Immunocompromised Children With Neutropenia
Official Title
Phase I-II Study of the Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children With Neutropenia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2004
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Neutropenia, Unspecified Childhood Solid Tumor, Protocol Specific
Keywords
infection, neutropenia, unspecified childhood solid tumor, protocol specific

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
anidulafungin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas J. Walsh, MD
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lombardi Cancer Center at Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010-2970
Country
United States
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105-2794
Country
United States

12. IPD Sharing Statement

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Anidulafungin in Treating Immunocompromised Children With Neutropenia

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