Children ages 2-17 with neutropenia (absolute count less than or equal 5000/mm(3)) and one or more of the following conditions: leukemia or lymphoma, excluding those patient's on maintenance therapy; bone marrow or peripheral stem cell transplantation; aplastic anemia; myelodysplastic syndrome; chemotherapy anticipated to incur greater than 10 days of neutropenia.
Patients with new onset of fever during neutropenia who will be initiated onto broad spectrum empirical antibacterial therapy.
Patients must have sufficient venous access to permit administration of study drug, collection of pharmacokinetic samples and monitoring of safety variables.
Concomitant therapies: Patients may have received or continue to receive antineoplastic therapies and medications for supportive care.
Females of childbearing potential must have a negative pregnancy test and must agree to use barrier methods of contraception throughout the study.
Informed consent of the patient, parent, or legally authorized representative obtained prior to entry.
Verbal assent will be obtained from minors capable of understanding.
No patients with active proven deeply invasive fungal infection.
No patients with moderate or severe liver disease, as defined by: AST or ALT greater than 2.5 times the upper limit of normal or total bilirubin greater than 2.5 times the upper limit of normal.
No patients who have received intravenous amphotericin B or formulations of amphotericin B within 72 hours of entering the study or who require treatment with systemic antifungal agents other than FK463. Patients may continue to receive fluconazole prophylactically (no more than 400mg/day or 12mg/kg/day) while on study. All other systemic antifungals agents must be discontinued prior to the first dose of FK463.
No patients who are on other phase I trials of investigational agents.
No patients previously enrolled into this study.
No other concomitant condition which, in the opinion of the investigator, would preclude a patient's participation in the study.