Anidulafungin in Treating Immunocompromised Children With Neutropenia - Full Text View

Sponsored by:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00068471

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 I Phase II

Study Type:	Interventional
Study Design:	Supportive Care, Open Label
Official Title:	Phase I-II Study of the Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children With Neutropenia

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Anidulafungin

U.S. FDA Resources

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

Study Start Date:

July 2003

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

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

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Thomas J. Walsh, MD

NCI - Pediatric Oncology Branch

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000322888, NCI-03-C-0229C
Study First Received:	September 10, 2003
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00068471 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

infection
neutropenia
unspecified childhood solid tumor, protocol specific

Study placed in the following topic categories:

Anti-Bacterial Agents
Neutropenia
Hematologic Diseases
Antifungal Agents
Agranulocytosis

Leukocyte Disorders
Leukopenia
Granulocytopenia
Anidulafungin

Additional relevant MeSH terms:

Anti-Infective Agents
Neutropenia
Hematologic Diseases
Therapeutic Uses
Antifungal Agents
Antibiotics, Antifungal

Agranulocytosis
Leukocyte Disorders
Leukopenia
Infection
Pharmacologic Actions
Anidulafungin

ClinicalTrials.gov processed this record on July 02, 2009