Phase I-II Study of the Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children With Neutropenia
2 Years
17 Years
Both
Infection, Neutropenia, Unspecified Childhood Solid Tumor, Protocol Specific
Trial Information
Phase I-II Study of the Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children With Neutropenia
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Supportive Care
Principal Investigator
Thomas J. Walsh, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Cancer Institute (NCI)
Authority:
United States: Federal Government
Study ID:
CDR0000322888
NCT ID:
NCT00068471
Start Date:
July 2003
Completion Date:
October 2007
Related Keywords:
- Infection
- Neutropenia
- Unspecified Childhood Solid Tumor, Protocol Specific
- infection
- neutropenia
- unspecified childhood solid tumor, protocol specific
- Neutropenia
Name | Location |
|---|---|
| Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
| Children's National Medical Center | Washington, District of Columbia 20010-2970 |
| St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
| Lombardi Cancer Center at Georgetown University Medical Center | Washington, District of Columbia 20007 |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda, Maryland 20892-1182 |
