Liposomal Amphotericin B (Ambisome) Versus Oral Voriconazole for the Prevention of Invasive Fungal Infections

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

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 voriconazole in the prevention of fungal infections in patients with acute myeloid leukemia (AML) or myelodysplastic syndromes MDS who are receiving chemotherapy. The safety of these treatments will also be studied and compared.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Amphotericin B; Liposomal amphotericin B; Voriconazole

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 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.