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


Phase 3
18 Years
N/A
Not Enrolling
Both
Leukemia, Fungal Infection

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Trial Information

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


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.


Inclusion Criteria:



1. Diagnosis of hematologic malignancy with indication to receive antifungal
prophylaxis.

2. Age >/= 18 years.

3. Patients must sign an informed consent.

Exclusion Criteria:

1. Patients with history of anaphylaxis attributed to azole compounds: voriconazole,
itraconazole, fluconazole, posaconazole

2. Patients with clinical or other evidence that indicates that they have proven or
probable invasive fungal infection prior to enrollment (European Organisation for
Research and Treatment of Cancer (EORTC) criteria).

3. Patients with total bilirubin levels > 3 times the upper normal limits (i.e. > 3.0
mg/dl); or aspartate aminotransferase (AST or SGOT) or alanine aminotransferase (ALT
or SGPT)> 5 times upper limit normal.

4. Patients receiving any medication that is contraindicated with the use of
voriconazole. Voriconazole is contraindicated with the co-administration of the
following drugs:sirolimus, terfenadine, astemizole, cisapride, pimozide, quinidine,
ergot alkaloids, rifabutin, rifampin, high-dose ritonavir (400 mg Q12h),
carbamazepine, long-acting barbiturates, efavirenz (with standard dose vfend and
efavirenz), St. John's Wort.

5. Patients currently receiving voriconazole for antifungal prophylaxis.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Samples With BG Levels > 60pg/ml

Outcome Description:

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.

Outcome Time Frame:

Up to 42 days

Safety Issue:

No

Principal Investigator

Jorge Cortes, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2008-0443

NCT ID:

NCT00904995

Start Date:

May 2009

Completion Date:

July 2010

Related Keywords:

  • Leukemia
  • Fungal Infection
  • Leukemia
  • Cancer of the blood
  • Cancer of the bone marrow
  • Hematologic malignancy
  • Invasive fungal infection
  • Voriconazole
  • Vfend
  • antifungal prophylaxis
  • Leukemia
  • Mycoses
  • Hematologic Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030