Open, Randomized Comparative Trial of Two Different Schedules of Liposomal Amphotericin B Versus Oral Voriconazole for the Prevention of Invasive Fungal Infections
Ambisome and voriconazole are drugs that have been used to fight fungal infections, which
typically occur during chemotherapy as a result of lowered immune system functioning.
Ambisome works by binding to the sterol component of the fungal cell membrane. This causes
"holes" to appear in the membrane, which leads to death of the fungal cell. Voriconazole
inhibits an essential step of the biosynthesis of an important component of the fungal cell
wall (ergosterol). This causes the impairment of the fungal cell wall.
Before you can start treatment on this study, you will have "screening tests." These tests
will help the doctor decide if you are eligible to take part in this study. You will be
asked questions about your medical history. You will have a complete physical exam and a
chest x-ray. You will have computed tomography (CT) scans of the chest. You will also have
about 1 teaspoon of blood drawn for routine tests. Test results from the pregnancy test that
you will have before your leukemia treatment will be looked at for this study. You will not
have a pregnancy test performed for this study.
If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the roll of dice) to one of 3 treatment groups (Group 1, Group 2, or Group 3).
Participants in Groups 1 and 2 will receive treatment with ambisome. Participants in Group 3
will receive treatment with voriconazole. Participants in all 3 groups will begin treatment
24 hours after the last dose of chemotherapy.
If you are assigned to Group 1, you will receive ambisome by vein as a continuous infusion
over 2 hours 1 time per day, 3 times each week.
If you are assigned to Group 2, you will receive ambisome by vein as a continuous infusion
over 2 hours 1 time per week.
If you are assigned to Group 3, you will take 2 pills by mouth (1 hour after breakfast) and
2 pills by mouth (1 hour after dinner) for 1 day, which amounts to 4 pills in total on Day
1. You will then take 1 pill by mouth (1 hour after breakfast) and 1 pill by mouth (1 hour
after dinner) everyday for the remainder of this study, which amounts to 2 pills in total
You will have about 1 teaspoon of blood drawn for routine tests 2 times each week. You will
also receive treatment with standard of care medications. These medications (which will be
specified by your doctor) will be used to help decrease the risk of developing bacterial
infections and viral infections.
If you develop a fever during treatment on this study, you will have a chest x-ray and a CT
scan of the chest within 3 days after the fever started.
You may remain on this study for up to 35 days (if you are receiving chemotherapy for the
first time) and up to 42 days (if you have had prior chemotherapy). Your participation may
end on this study if your study doctor thinks it is necessary, if other antifungal therapy
is required, or if you develop any intolerable side effects.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Number of Participants With Invasive Fungal Infection
Endpoint was whether participant had an invasive fungal infection or not, a potentially fatal complication with leukemia patients. Efficacy defined as absence of proven and probable fungal infection. Probable fungal infection is: 1) Positive radiographic findings consistent with fungal infections documented on CT imaging: Lower respiratory tract infection: halo sign, air crescent-sign, or cavity within areas of consolidation; Sinus: erosion of sinus walls or extension of infection to neighboring structures, extensive skull base destruction; and/or 2) Two positive galactomannan index test.
35 days from the start of therapy for induction participants and 42 days for salvage participants.
Gloria N Mattiuzzi, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|The University of Texas M D Anderson Cancer Center||Houston, Texas 77030|