Beta Glucan Assay in Patients Receiving Voriconazole Prophylaxis

NCT00904995

Last updated date
Study Location
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Leukemia, Fungal Infection
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

2. Age >/= 18 years.

3. Patients must sign an informed consent.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Leukemia, Fungal InfectionBeta Glucan Assay in Patients Receiving Voriconazole Prophylaxis
NCT00904995
  1. Houston, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Beta Glucan Assay in Patients Receiving Voriconazole Prophylaxis
Official Title  ICMJE Kinetics of 1, 3 Beta-d- Glucan Assay in Patients With Hematologic Malignancies Receiving Voriconazole Prophylaxis
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Leukemia
  • Fungal Infection
Intervention  ICMJE
  • Drug: Voriconazole
    Starting dose of 400 mg by mouth twice a day for first day, followed by 200 mg by mouth twice a day thereafter.
    Other Name: Vfend
  • Drug: Voriconazole
    6 mg/kg by vein for first dose, followed by 200 mg by mouth twice a day thereafter.
    Other Name: Vfend
Study Arms  ICMJE
  • Experimental: Group 1 - Oral
    Voriconazole Starting oral dose of 400 mg pills twice a day for first day, followed by 200 mg by mouth twice a day thereafter.
    Intervention: Drug: Voriconazole
  • Experimental: Group 2 - IV + Oral
    Voriconazole 6 mg/kg by vein (IV) first dose then 200 mg pills two times a day thereafter.
    Intervention: Drug: Voriconazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 30, 2010)
23
Original Estimated Enrollment  ICMJE
 (submitted: May 19, 2009)
20
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00904995
Other Study ID Numbers  ICMJE 2008-0443
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Chair:Jorge Cortes, MDUT MD Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP