Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00418951
Status:
COMPLETED
Last Update Posted:
2012-08-07
First Post:
2007-01-03
Brief Title:
Liposomal Amphotericin B Ambisome Versus Oral Voriconazole for the Prevention of Invasive Fungal Infections
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Open Randomized Comparative Trial of Two Different Schedules of Liposomal Amphotericin B Versus Oral Voriconazole for the Prevention of Invasive Fungal Infections
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical research study is to compare the effectiveness of liposomal amphotericin B given three times per week versus liposomal amphotericin B given once per week versus oral voriconazole in the prevention of fungal infections in patients with acute myeloid leukemia AML or myelodysplastic syndromes MDS who are receiving chemotherapy The safety of these treatments will also be studied and compared
Detailed Description:
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 each day
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
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 each day
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None