A Phase I-II Safety, Tolerability And Pharmacokinetic Study Of Ravuconazole For Prophylaxis Of Invasive Fungal Infections In Patients Undergoing Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation
- 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
- Determine the effect of this drug on concurrently administered cyclosporine in these
- Determine the pharmacokinetics of this drug with and without cyclosporine in these
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.
Masking: Open Label, Primary Purpose: Supportive Care
Thomas J. Walsh, MD
National Cancer Institute (NCI)
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|