Caspofungin Acetate, Fluconazole, or Voriconazole in Preventing Fungal Infections in Patients Following Donor Stem Cell Transplant
Condition: Fungal Infection; Hematopoietic and Lymphoid Cell Neoplasm
MeSH terms: Infections; Communicable Diseases; Mycoses
Intervention: Caspofungin Acetate; Fluconazole; Laboratory Biomarker Analysis; Voriconazole
Intervention description: Given IV; Given IV or PO; Optional correlative studies; Given IV or PO
Intervention MeSH terms: Fluconazole; Voriconazole; Caspofungin
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 292.0
Sex: All
Minimum age: 3 Months
Maximum age: 20 Years
Healthy volunteers: No

Summary:

      This randomized phase III trial studies how well caspofungin acetate works compared to
      fluconazole or voriconazole in preventing fungal infections in patients following donor stem
      cell transplant. Caspofungin acetate, fluconazole, and voriconazole may be effective in
      preventing fungal infections in patients following donor stem cell transplant. It is not yet
      known whether caspofungin acetate is more effective than fluconazole or voriconazole in
      preventing fungal infections in patients following donor stem cell transplant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age

               -  For centers that will use fluconazole as the antifungal comparator:

                    -  Age >= 3 months and < 21 years

               -  For centers that will use voriconazole as the antifungal comparator:

                    -  Age >= 2 years and < 21 years

          -  The patient must be undergoing allogeneic HCT from any donor (including matched
             related) with any stem cell source for any underlying condition

          -  Patients must have a performance status corresponding to Eastern Cooperative Oncology
             Group (ECOG) scores of 0, 1 or 2; use Karnofsky for patients > 16 years of age and
             Lansky for patients =< 16 years of age

          -  Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
             mL/min/1.73 m^2 OR a serum creatinine based on age/gender as follows:

               -  0.4 mg/dL (1 month to < 6 months of age)

               -  0.5 mg/dL (6 months to < 1 year of age)

               -  0.6 mg/dL (1 to < 2 years of age)

               -  0.8 mg/dL (2 to < 6 years of age)

               -  1.0 mg/dL (6 to < 10 years of age)

               -  1.2 mg/dL (10 to < 13 years of age)

               -  1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to < 16 years of age)

               -  1.7 mg/dL (male) or 1.4 mg/dL (female) (>= 16 years of age)

          -  Total bilirubin < 2.5 mg/dL unless the increase in bilirubin is attributable to
             Gilbert's syndrome

          -  Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or
             serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 5 x
             upper limit of normal (ULN) for age

          -  All patients and/or their parents or legal guardians must sign a written informed
             consent

          -  All institutional, Food and Drug Administration (FDA), and National Cancer Institute
             (NCI) requirements for human studies must be met

        Exclusion Criteria:

          -  Within 90 days of enrollment:

               -  Patients with a proven or probable invasive mold infection are not eligible

               -  Patients with an incompletely treated invasive yeast infection are not eligible

               -  Patients with an elevated galactomannan level (>= 0.5 index) within 30 days prior
                  to time of enrollment (if performed) must have a full evaluation for invasive
                  aspergillosis (including a negative chest computed tomography [CT] scan) during
                  that time period to be eligible for enrollment

          -  Patients receiving treatment for an IFI are not eligible

          -  Patients with a history of echinocandin or azole hypersensitivity are not eligible

          -  Female patients of childbearing potential are not eligible unless a negative pregnancy
             test result has been obtained

          -  Sexually active patients of reproductive potential are not eligible unless they have
             agreed to use an effective contraceptive method for the duration of their study
             participation

          -  Lactating females are not eligible unless they have agreed not to breastfeed their
             infants