Infections

All Conditions

Neoplasms

Blood and Lymph Conditions

Symptoms and General Pathology

Musculoskeletal Diseases

Mycoses

Leukemia

Hematologic Neoplasms

Communicable Diseases

Invasive Fungal Infections

Bone Neoplasms

Bacterial Infections

Bacterial Infections and Mycoses

Anti-Infective Agents

All Drugs and Chemicals

Voriconazole

Clotrimazole

Miconazole

Antifungal Agents

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Hormones

Hormone Antagonists

Cytochrome P-450 CYP3A Inhibitors

Voriconazole Starting oral dose of 400 mg pills twice a day for first day, followed by 200 mg by mouth twice a day thereafter.

Voriconazole 6 mg/kg by vein (IV) first dose then 200 mg pills two times a day thereafter.

Starting dose of 400 mg by mouth twice a day for first day, followed by 200 mg by mouth twice a day thereafter.

6 mg/kg by vein for first dose, followed by 200 mg by mouth twice a day thereafter.

Jorge Cortes, MD

Objectives:

To investigate the relationship between the administration of intravenous (IV) and oral voriconazole (vori) and the occurrence of false positive (1,3) beta-d- glucan (BG) relative to the standard assessment criteria used to diagnose invasive fungal infection in patients with hematologic malignancies.

Chemotherapy can lower immune system function, which can cause fungal infections to occur more easily. These fungal infections are found by certain blood tests. One of these blood tests looks for a part of the fungal cell floating freely in the human blood.

When certain drugs are given to patients to prevent fungal infections, these blood tests may show that there is an infection when there actually is not one present. Some of these drugs are similar to the study drug voriconazole.

The Study Drug:

Voriconazole is designed to slow the growth of fungal cells, which may cause the fungal cells to die.

Screening Tests:

Signing this consent form does not mean that you will be able to take part in this study. You will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed:

* Your medical history will be recorded.
* You will have a complete physical exam.
* Blood (about 1 teaspoon) will be drawn for routine tests.
* If your doctor thinks it is needed, you will have a chest x-ray or computed tomography (CT) scan of the chest to check for pneumonia.

The study doctor will discuss the screening test results with you. If the screening tests show that you are not eligible to take part in the study, you will not be enrolled. Other treatment options will be discussed with you.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to 1 of 2 study groups. Group 1 will consist of the first 10 patients enrolled on the study. Group 2 will consist of the next 10 patients enrolled on the study. If you are in Group 1, you will take only pills of study drug 2 times every day while you are on study. If you are in Group 2, you will receive the study drug through a needle in your vein 1 time when you begin the study and then take pills of study drug 2 times every day for the rest of the time you are on study.

Blood Draws for Fungal Infection Tests:

If you are in Group 1, blood (about 1 teaspoon each time) will be drawn for fungal infection tests at the following times:

* Before the first dose of study drug.
* 1, 2, 4, and 8 hours after the first dose of study drug.
* Before the third dose of study drug.
* 1, 2, 4, and 8 hours after the third dose of study drug.

If you are in Group 2, blood (about 1 teaspoon each time) will be drawn for fungal infection tests at the following times:

* Before the first dose of study drug.
* 1, 2, 4, and 8 hours after the first dose of study drug.
* 1, 2, and 4 hours after the second dose of study drug.

Length of Study:

You may continue taking the study drug for up to 35 days if you are receiving chemotherapy for the first time and up to 42 days if you have had chemotherapy before. Your doctor may decide that you should take the study drug for an even longer period of time or that you need to have another drug to prevent fungal infections. You will be taken off study if intolerable side effects occur or if you get a fungal infection.

Additional Information:

There are several drugs that should not be taken in combination with voriconazole. You should talk to the study doctor about any drugs you may be taking and about any drugs you may plan to start taking while on study. You should also avoid eating/drinking grapefruit/grapefruit products while you are on study, as they may interfere with the effects of the study drug.

This is an investigational study. Voriconazole is FDA approved and commercially available for the treatment of fungal infections.

Up to 20 patients who are found to be eligible after screening will take part in this study. All will be enrolled at M. D. Anderson.

Beta Glucan Assay in Patients Receiving Voriconazole Prophylaxis

Kinetics of 1, 3 Beta-d- Glucan Assay in Patients With Hematologic Malignancies Receiving Voriconazole Prophylaxis

Rate calculated as number of participants with positive levels divided by total number of participants. beta-d-glucan (BG), a cell wall constituent of fungi, can be detected in serum as a marker of Invasive fungal infections (IFI).

Blood samples were drawn on first 2 days of treatment at baseline (before the drug) and at 1, 2, 4, 8 hours after the first dose of the day. BG serum levels were measured using the Fungitell assay, using a cut off value of 60 pg/ml for positivity.

Pfizer

M.D. Anderson Cancer Center

Voriconazole starting oral dose of 400 mg pills twice a day for first day, followed by 200 mg by mouth twice a day thereafter.

Group 1 - Oral

Group 2 - IV + Oral

Total

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Jorge Cortes, MD / Professor

Samples BG levels > 60pg/ml, First Test

Samples BG levels > 60pg/ml, Following Re-Test

Analysis was intent to treat with a total of 182 samples (mean 8.6 samples/participant) drawn from participants.

Percentage of Samples With BG Levels > 60pg/ml

Overall Study

Rare Diseases

Syndrome

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Neoplasms by Histologic Type

Hematologic Diseases

Bone Marrow Diseases

Precancerous Conditions

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Amphotericin B

Liposomal amphotericin B

Amebicides

Antiprotozoal Agents

Antiparasitic Agents

Anti-Bacterial Agents

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

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

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

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

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

Gloria N Mattiuzzi, MD

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.

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.

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

Open, Randomized Comparative Trial of Two Different Schedules of Liposomal Amphotericin B Versus Oral Voriconazole for the Prevention of Invasive Fungal Infections

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Beta Glucan Assay in Patients Receiving Voriconazole Prophylaxis	NCT00904995	Leukemia Fungal Infectio...	Voriconazole Voriconazole	18 Years -	M.D. Anderson Cancer Center
Beta Glucan Assay in Patients Receiving Voriconazole Prophylaxis	NCT00904995	Leukemia Fungal Infectio...	Voriconazole Voriconazole	18 Years -	M.D. Anderson Cancer Center
Liposomal Amphotericin B (Ambisome) Versus Oral Voriconazole for the Prevention of Invasive Fungal Infections	NCT00418951	Acute Myelogeno... Myelodysplastic...	Voriconazole Liposomal ampho... Liposomal ampho...	18 Years -	M.D. Anderson Cancer Center

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Every month we try and update this database with for vfend cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for vfend

Every month we try and update this database with for vfend cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for vfend cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.