Anidulafungin in Treating Immunocompromised Children With Neutropenia

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00068471

Collaborator

(none)

Locations

Duration (Months)

Study Details

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.

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

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.

Study Design

Study Type:

Interventional

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 :

Jul 1, 2003

Actual Study Completion Date :

Oct 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 17 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lombardi Cancer Center at Georgetown University Medical Center	Washington	District of Columbia	United States	20007
2	Children's National Medical Center	Washington	District of Columbia	United States	20010-2970
3	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland	United States	20892-1182
4	Duke Comprehensive Cancer Center	Durham	North Carolina	United States	27710
5	St. Jude Children's Research Hospital	Memphis	Tennessee	United States	38105-2794