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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00418951 |
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 AML or MDS who are receiving chemotherapy. The safety of these treatments will also be studied and compared.
Condition | Intervention | Phase |
---|---|---|
Acute Myelogenous Leukemia Myelodysplastic Syndrome |
Drug: Voriconazole Drug: Ambisome |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Open, Randomized Comparative Trial of Two Different Schedules of Liposomal Amphotericin B Versus Oral Voriconazole for the Prevention of Invasive Fungal Infections |
Estimated Enrollment: | 150 |
Study Start Date: | November 2006 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Gloria N Mattiuzzi, MD | 713-745-2723 | gmattiuz@mdanderson.org |
Contact: Jorge E Cortes, MD | 713-794-5783 | jcortes@mdanderson.org |
United States, Texas | |
The University of Texas M D Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Gloria N Mattiuzzi, MD 713-745-2723 gmattiuz@mdanderson.org | |
Principal Investigator: Gloria N Mattiuzzi, MD | |
Sub-Investigator: Gloria N Mattiuzzi, MD |
Principal Investigator: | Gloria N Mattiuzzi, MD | M.D. Anderson Cancer Center |
Study Director: | Gloria N Mattiuzzi, MD | The University of Texas MD Anderson Cancer Center |
Study ID Numbers: | 2006-0536 |
Study First Received: | January 3, 2007 |
Last Updated: | October 3, 2007 |
ClinicalTrials.gov Identifier: | NCT00418951 |
Health Authority: | United States: Institutional Review Board |
Voriconazole Ambisome Acute Myelogenous Leukemia |
Myelodysplastic Syndrome AML MDS |
Abelcet Myelodysplastic syndromes Amphotericin B Precancerous Conditions Clotrimazole Hematologic Diseases Miconazole Myelodysplastic Syndromes Myelodysplasia Tioconazole |
Acute myelogenous leukemia Leukemia, Myeloid Liposomal amphotericin B Leukemia, Myeloid, Acute Mycoses Leukemia Preleukemia Voriconazole Bone Marrow Diseases Acute myelocytic leukemia |
Anti-Infective Agents Antiprotozoal Agents Neoplasms by Histologic Type Disease Pharmacologic Actions Anti-Bacterial Agents Neoplasms |
Antiparasitic Agents Pathologic Processes Syndrome Therapeutic Uses Antifungal Agents Antibiotics, Antifungal Amebicides |