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Liposomal Amphotericin B (Ambisome) Versus Oral Voriconazole for the Prevention of Invasive Fungal Infections

NCT ID: NCT00418951

Last Updated: 2012-08-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2009-10-31

Brief Summary

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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

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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.

Conditions

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Acute Myelogenous Leukemia Myelodysplastic Syndrome

Keywords

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Voriconazole Vfend Liposomal amphotericin B Ambisome Acute Myelogenous Leukemia Myelodysplastic Syndrome AML MDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Liposomal amphotericin B: 3 mg/kg

3 mg/kg intravenously (IV) three times per week

Group Type EXPERIMENTAL

Liposomal amphotericin B

Intervention Type DRUG

3 mg/kg intravenously three times per week over 2 hours +/- 15 minutes

Liposomal amphotericin B: 9 mg/kg

9 mg/kg IV once per week

Group Type EXPERIMENTAL

Liposomal amphotericin B

Intervention Type DRUG

9 mg/kg intravenously once per week over 2 hours +/- 15 minutes

Voriconazole: 400 mg

400 mg oral twice daily day 1 followed by 200 mg twice daily

Group Type EXPERIMENTAL

Voriconazole

Intervention Type DRUG

400 mg by mouth twice daily on day 1, followed by 200 mg by mouth twice daily

Interventions

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Voriconazole

400 mg by mouth twice daily on day 1, followed by 200 mg by mouth twice daily

Intervention Type DRUG

Liposomal amphotericin B

3 mg/kg intravenously three times per week over 2 hours +/- 15 minutes

Intervention Type DRUG

Liposomal amphotericin B

9 mg/kg intravenously once per week over 2 hours +/- 15 minutes

Intervention Type DRUG

Other Intervention Names

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Vfend Ambisome Ambisome

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of AML or high risk MDS undergoing induction chemotherapy or first salvage chemotherapy.
* Age \>/=18 years.
* Patients must sign an informed consent.

Exclusion Criteria

* Patients with history of anaphylaxis attributed to azole or amphotericin B compounds.
* Patients with clinical or other evidence that indicates that they have proven or probable invasive fungal infection prior to enrollment.
* Patients with total bilirubin levels \> 3 times the upper normal limits (i.e. \> 3.0 mg/dl); or serum glutamic pyruvic transaminase (SGPT)\> 5 times upper limit normal.
* Patients with serum creatinine \> 2.0 mg/dl.
* Patients receiving any medication that is contraindicated with the use of voriconazole.
* Patients who have participated in this study during induction chemotherapy.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gloria N Mattiuzzi, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Gloria N Mattiuzzi, MD

Role: STUDY_DIRECTOR

The University of Texas MD Anderson Cancer Center

Locations

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The University of Texas M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://mdanderson.org

M.D. Anderson's website

Other Identifiers

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2006-0536

Identifier Type: -

Identifier Source: org_study_id