A Prospective, Randomized, Double-Blind, Multicenter Pilot Study Of The Safety And Efficacy Of Interferon Gamma- 1b (IFN-y 1b) Plus Voriconazole Versus Placebo Plus Voriconazole In The Treatment Of Invasive Aspergillosis And Other Filamentous Fungal Infections
- Determine the safety profile of voriconazole and interferon gamma in patients with
invasive aspergillosis or other filamentous fungal infections.
- Compare the efficacy and possible heterogeneity in efficacy of voriconazole with or
without interferon gamma across different patient sub-populations, in terms of
designing a larger phase II or pivotal phase III study.
- Determine the time to partial or complete response and rate of response (at weeks 6 and
12 or at end of treatment and follow-up) in patients receiving interferon gamma.
- Compare the proportion of patients with at least a two-fold reduction in the
galactomannan antigenemia titer at 6 and 12 weeks or at end of treatment with these
- Determine surrogate immunologic markers for response to interferon gamma, functional
integrity and anti-fungal activity of phagocytic cells (neutrophils, monocytes, and
macrophages), and nonphagocytic effector cells (natural killer and T cells) in these
OUTLINE: This is a randomized, double-blind, multicenter, pilot study. Patients are
stratified according to age (under 18 vs 18 and over) and absolute neutrophil count (less
than 500/mm^3 vs at least 500/mm^3). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive voriconazole (IV over 80-120 minutes for the first 3 doses and
orally every 12 hours for subsequent doses) 3 times per week and interferon gamma
subcutaneously (SC) 3 times per week.
- Arm II: Patients receive voriconazole as in arm I and placebo SC 3 times per week.
In both arms, treatment continues for 12 weeks in the absence of disease progression or
Patients are followed at 4 weeks.
PROJECTED ACCRUAL: A total of 88 patients (44 per treatment arm) will be accrued for this
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Thomas J. Walsh, MD
National Cancer Institute (NCI)
United States: Federal Government
|Arkansas Cancer Research Center at University of Arkansas for Medical Sciences||Little Rock, Arkansas 72205|
|Shands Cancer Center at the University of Florida Health Science Center||Gainesville, Florida 32610-0296|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|