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Liposomal Amphotericin B (Ambisome) Versus Oral Voriconazole for the Prevention of Invasive Fungal Infections
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, October 2007
Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00418951
  Purpose

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 AML or MDS who are receiving chemotherapy. The safety of these treatments will also be studied and compared.


Condition Intervention Phase
Acute Myelogenous Leukemia
Myelodysplastic Syndrome
Drug: Voriconazole
Drug: Ambisome
Phase II

MedlinePlus related topics: Cancer Fungal Infections Leukemia, Adult Acute Leukemia, Adult Chronic Molds
Drug Information available for: Amphotericin B Voriconazole
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title: Open, Randomized Comparative Trial of Two Different Schedules of Liposomal Amphotericin B Versus Oral Voriconazole for the Prevention of Invasive Fungal Infections

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To evaluate and compare-
  • the safety (absence of grade 3-4 toxicity) and efficacy (absence of proven and probable fungal infection) of liposomal amphotericin B given three times per week
  • versus liposomal amphotericin B given once per week, versus oral vori.

Secondary Outcome Measures:
  • To determine-
  • time to failure of prophylaxis
  • frequency and time to empiric antifungal therapy
  • number of patients with positive galactomannan index
  • and, duration of positive antigenemia.

Estimated Enrollment: 150
Study Start Date: November 2006
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00418951

Contacts
Contact: Gloria N Mattiuzzi, MD 713-745-2723 gmattiuz@mdanderson.org
Contact: Jorge E Cortes, MD 713-794-5783 jcortes@mdanderson.org

Locations
United States, Texas
The University of Texas M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Gloria N Mattiuzzi, MD     713-745-2723     gmattiuz@mdanderson.org    
Principal Investigator: Gloria N Mattiuzzi, MD            
Sub-Investigator: Gloria N Mattiuzzi, MD            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Gloria N Mattiuzzi, MD M.D. Anderson Cancer Center
Study Director: Gloria N Mattiuzzi, MD The University of Texas MD Anderson Cancer Center
  More Information

((M.D. Anderson's website))  This link exits the ClinicalTrials.gov site

Study ID Numbers: 2006-0536
Study First Received: January 3, 2007
Last Updated: October 3, 2007
ClinicalTrials.gov Identifier: NCT00418951  
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Voriconazole
Ambisome
Acute Myelogenous Leukemia
Myelodysplastic Syndrome
AML
MDS

Study placed in the following topic categories:
Abelcet
Myelodysplastic syndromes
Amphotericin B
Precancerous Conditions
Clotrimazole
Hematologic Diseases
Miconazole
Myelodysplastic Syndromes
Myelodysplasia
Tioconazole
Acute myelogenous leukemia
Leukemia, Myeloid
Liposomal amphotericin B
Leukemia, Myeloid, Acute
Mycoses
Leukemia
Preleukemia
Voriconazole
Bone Marrow Diseases
Acute myelocytic leukemia

Additional relevant MeSH terms:
Anti-Infective Agents
Antiprotozoal Agents
Neoplasms by Histologic Type
Disease
Pharmacologic Actions
Anti-Bacterial Agents
Neoplasms
Antiparasitic Agents
Pathologic Processes
Syndrome
Therapeutic Uses
Antifungal Agents
Antibiotics, Antifungal
Amebicides

ClinicalTrials.gov processed this record on January 14, 2009