Clinical trial NCT00904995
Conditions: Leukemia Fungal Infection
Keywords: Leukemia Cancer of the blood Cancer of the bone marrow Hematologic malignancy Invasive fungal infection Voriconazole Vfend antifungal prophylaxis
Sponsor: M.D. Anderson Cancer Center
Start date: 2009-05-01; Completion date: 2010-07-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
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.

Detailed description:
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.

Arms: arm 1: Voriconazole Starting oral dose of 400 mg pills twice a day for first day, followed by 200 mg by mouth twice a day thereafter. arm 2: Voriconazole 6 mg/kg by vein (IV) first dose then 200 mg pills two times a day thereafter.
Interventions: intervention 1: Voriconazole intervention 2: Voriconazole
Intervention descriptions: intervention 1: Starting dose of 400 mg by mouth twice a day for first day, followed by 200 mg by mouth twice a day thereafter. intervention 2: 6 mg/kg by vein for first dose, followed by 200 mg by mouth twice a day thereafter.

Protocol documents: