Anidulafungin in Treating Immunocompromised Children With Neutropenia
Infection, Neutropenia, Unspecified Childhood Solid Tumor, Protocol Specific
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
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