Comparing the Effectiveness of Fluconazole and a New Medicine (FK463) in Preventing Fungal Infections in Bone Marrow Transplant Patients

Inclusion Criteria

• •Informed consent of the patient or legally authorized representative must be obtained prior to entry.
• •Verbal assent will be obtained from minors capable of understanding.
• •Patients may be of either gender. Females of childbearing potential must have a negative pregnancy test obtained within 14 days prior to the first dose of study drug.
• •Patients greater than or equal to 6 months of age.
• •Patients at risk of systemic fungal infections due to their immunocompromised state due to one of the following:
• •Patient with a hematologic malignancy undergoing an autologous hematopoietic stem cell transplant;
• •Any patient undergoing an allogeneic hematopoietic stem cell transplant.
• •Patients must have sufficient venous access to permit administration of study drug and monitoring of safety variables.
• •No patients who are pregnant or nursing. Females of childbearing potential must avoid becoming pregnant by abstinence or barrier methods of birth control while receiving antifungal agents.
• •No patients with moderate or severe liver disease, as defined by:
• •AST or ALT greater than 5 times upper limit of normal (ULN), OR;
• •Total bilirubin greater than 2.5 times ULN.
• •No patients with evidence of a deeply invasive or disseminated fungal infection at time of enrollment.
• •No patients who have received systemic antifungal agents within 72 hours prior to the first dose of study drug.
• •No patients receiving an autologous transplant for nonhematologic malignancies.
• •No patients known to be infected with HIV due to the lack of data on drug interaction between highly active antiretroviral therapy (HAART) and FK463.
• •No patients previously randomized in this study.
• •No patients with a history of anaphylaxis attributed to azole compounds or the echinocandin class or antifungals.
• •No patients with a concomitant medical condition, in the opinion of the investigator and/or medical monitor, whose participation may create an unacceptable additional risk for the patient.
• •No patients receiving another investigational drug other than for the treatment of cancer or supportive care.