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


Phase 2
18 Years
N/A
Not Enrolling
Both
Acute Myelogenous Leukemia, Myelodysplastic Syndrome

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Trial Information

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


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.


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 serum glutamic pyruvic transaminase (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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Number of Participants With Invasive Fungal Infection

Outcome Description:

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.

Outcome Time Frame:

35 days from the start of therapy for induction participants and 42 days for salvage participants.

Safety Issue:

No

Principal Investigator

Gloria N Mattiuzzi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2006-0536

NCT ID:

NCT00418951

Start Date:

November 2006

Completion Date:

October 2009

Related Keywords:

  • Acute Myelogenous Leukemia
  • Myelodysplastic Syndrome
  • Voriconazole
  • Vfend
  • Liposomal amphotericin B
  • Ambisome
  • Acute Myelogenous Leukemia
  • Myelodysplastic Syndrome
  • AML
  • MDS
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Mycoses
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

The University of Texas M D Anderson Cancer CenterHouston, Texas  77030