Anidulafungin in Treating Immunocompromised Children With Neutropenia
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on October 19, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infection; Neutropenia; Unspecified Childhood Solid Tumor, Protocol Specific
Intervention: anidulafungin (Drug); antifungal therapy (Procedure); infection prophylaxis/management (Procedure); supportive care/therapy (Procedure)
Phase: Phase 1/Phase 2
Status: Active, not recruiting
Sponsored by: National Cancer Institute (NCI) Official(s) and/or principal investigator(s):
Thomas J. Walsh, MD, Principal Investigator, Affiliation: NCI - Pediatric Oncology Branch
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.
Clinical Details
Official title:
Phase I-II Study of the Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children With Neutropenia
Study design: Interventional, Supportive Care, Open Label
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
Minimum age: 2 Years.
Maximum age: 17 Years.
Gender(s): Both.
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
Locations and Contacts
Children's National Medical Center, Washington, District of Columbia 20010-2970, United States
Lombardi Cancer Center at Georgetown University Medical Center, Washington, District of Columbia 20007, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda, Maryland 20892-1182, United States
Duke Comprehensive Cancer Center, Durham, North Carolina 27710, United States
St. Jude Children's Research Hospital, Memphis, Tennessee 38105-2794, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Last updated: February 20, 2007
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