Status:
COMPLETED
Liposomal Amphotericin B (Ambisome) Versus Oral Voriconazole for the Prevention of Invasive Fungal Infections
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Acute Myelogenous Leukemia
Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 voric...
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 bindin...
Eligibility Criteria
Inclusion
- Diagnosis of AML or high risk MDS undergoing induction chemotherapy or first salvage chemotherapy.
- Age \>/=18 years.
- Patients must sign an informed consent.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00418951
Start Date
November 1 2006
End Date
October 1 2009
Last Update
August 7 2012
Active Locations (1)
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1
The University of Texas M D Anderson Cancer Center
Houston, Texas, United States, 77030