Finding studies
Finding studies
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Lead
National Institutes of Health Clinical Center (CC)
With
OBJECTIVES: * Determine the safety and tolerability of ravuconazole for the prevention of invasive fungal infections in patients undergoing non-myeloablative allogeneic hematopoietic stem cell transplantation. * Determine the pharmacokinetics and efficacy of this drug, in terms of frequency of breakthrough fungal infections and requirement for empirical antifungal therapy, in these patients. * Determine the effect of this drug on concurrently administered cyclosporine in these patients. * Determine the pharmacokinetics of this drug with and without cyclosporine in these patients. OUTLINE: This is an open-label, dose-escalation study. Patients receive oral ravuconazole once daily beginning within 48 hours of the chemotherapy preparative regimen and before the initiation of cyclosporine. Treatment continues until blood counts recover in the absence of unacceptable toxicity. Cohorts of 8 patients receive escalating doses of ravuconazole until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 8 patients experience dose-limiting toxicity. Patients are followed at 4 weeks. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted