Status:
COMPLETED
Caspofungin Acetate, Fluconazole, or Voriconazole in Preventing Fungal Infections in Patients Following Donor Stem Cell Transplant
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Fungal Infection
Hematopoietic and Lymphoid Cell Neoplasm
Eligibility:
All Genders
3-20 years
Phase:
PHASE3
Brief 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. Cas...
Detailed Description
PRIMARY OBJECTIVES: I. To determine if caspofungin (caspofungin acetate) is associated with a lower incidence of proven/probable invasive fungal infections (IFI) during the first 42 days following al...
Eligibility Criteria
Inclusion
- 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:
- 4 mg/dL (1 month to \< 6 months of age)
- 5 mg/dL (6 months to \< 1 year of age)
- 6 mg/dL (1 to \< 2 years of age)
- 8 mg/dL (2 to \< 6 years of age)
- 0 mg/dL (6 to \< 10 years of age)
- 2 mg/dL (10 to \< 13 years of age)
- 5 mg/dL (male) or 1.4 mg/dL (female) (13 to \< 16 years of age)
- 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
- 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
Key Trial Info
Start Date :
March 21 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2021
Estimated Enrollment :
292 Patients enrolled
Trial Details
Trial ID
NCT01503515
Start Date
March 21 2013
End Date
September 30 2021
Last Update
October 16 2024
Active Locations (49)
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1
Phoenix Childrens Hospital
Phoenix, Arizona, United States, 85016
2
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
3
Children's Hospital and Research Center at Oakland
Oakland, California, United States, 94609-1809
4
Children's Hospital of Orange County
Orange, California, United States, 92868