Phase I Study of the Safety, Tolerance, and Pharmacokinetics of FK463 in Immunocompromised Children With Fever and Neutropenia

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

Keywords

ClinConnect Summary

The objective of this study is to evaluate the safety, tolerance, and pharmacokinetics of FK463, a novel echinocandin (cell wall-active antifungal lipopeptide), as early empirical therapy for prevention of fungal infections in immunocompromised children. The study is designed as a multicenter open label, sequential dose escalation study of intravenous FK463. Intravenous FK463 will be administered daily as a one hour infusion to patients with new onset of fever and neutropenia (absolute neutrophil count less than or equal to 500/mm3) who will be initiated onto broad spectrum empirical antiba...

Gender

ALL

Eligibility criteria

• • 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.