Diseases and Conditions Researched
Fungal Infection; Leukemia; Neutropenia
What is the purpose of this trial?
RATIONALE: Caspofungin acetate or fluconazole may help prevent fungal infections caused by chemotherapy. It is not yet known whether fluconazole is more effective than caspofungin acetate in preventing fungal infections in patients with acute myeloid leukemia who are undergoing chemotherapy.
PURPOSE: This randomized phase III clinical trial is studying caspofungin acetate to see how it works compared to fluconazole in preventing invasive fungal infections in patients with acute myeloid leukemia who are undergoing chemotherapy.
Participation Guidelines
Age:
Up to 30 Years
Gender: Both
Click here for
detailed participation information for this trial.
|
Sponsors:
|
Children's Oncology Group; National Cancer Institute (NCI) |
| Dates: |
March 1, 2011 |
| Last Updated: |
February 19, 2012 |
| Study HIC#: |
1112009412 |
| Clinicaltrials.gov ID: |
NCT01307579
|
Conditions
Fungal Infection; Leukemia; Neutropenia
Interventions Details
| Drug:
|
caspofungin acetate |
| Drug:
|
fluconazole |
Trial Phase
Phase 3
Trial Purpose
RATIONALE: Caspofungin acetate or fluconazole may help prevent fungal infections caused by chemotherapy. It is not yet known whether fluconazole is more effective than caspofungin acetate in preventing fungal infections in patients with acute myeloid leukemia who are undergoing chemotherapy.
PURPOSE: This randomized phase III clinical trial is studying caspofungin acetate to see how it works compared to fluconazole in preventing invasive fungal infections in patients with acute myeloid leukemia who are undergoing chemotherapy.
Participation Guidelines
Age:
Up to 30 Years
Gender: Both
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Patients must have one of the following diagnoses and/or treatment plans:
- Newly diagnosed de novo AML
- First or subsequent relapse of AML
- Secondary AML
- Planned treatment as per COG-AAML0531 (including those in whom it is planned to
not administer Intensification III) or AAML1031 for any diagnosis; either those
following these treatment plans or those enrolled on AAML1031 are eligible
- Patients with the following diagnoses are not eligible:
- Acute promyelocytic leukemia (APL)
- Down syndrome
- Juvenile myelomonocytic leukemia (JMML)
PATIENT CHARACTERISTICS:
- Creatinine clearance or radioisotope GFR = 70 mL/min OR a serum creatinine based on
age/gender as follows:
- = 0.4 mg/dL (age 1 month to < 6 months)
- = 0.5 mg/dL (age 6 months to < 1 year)
- = 0.6 mg/dL (age 1 to < 2 years)
- = 0.8 mg/dL (age 2 to < 6 years)
- = 1 mg/dL (age 6 to < 10 years)
- = 1.2 mg/dL (age 10 to < 13 years)
- = 1.4 mg/dL (females age = 13 years)
- = 1.5 mg/dL (males age 13 to < 16 years)
- = 1.7 mg/dL (males age = 16 years)
- Total bilirubin = 1.5 x upper limit of normal (ULN) for age AND SGOT (AST) or SGPT
(ALT) < 2.5 x ULN
- Lactating patients must agree not to nurse a child while on this trial
- Female patients of childbearing age must have a negative pregnancy test
- Patients must agree to use an effective birth control method
- Patients with a documented history of IFI within the previous 30 days are not
eligible
- Patients with a history of echinocandin or fluconazole hypersensitivity are not
eligible
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No other concurrent systemic antifungal therapy
Link
|
Sponsors:
|
Children's Oncology Group; National Cancer Institute (NCI) |
| Dates: |
March 1, 2011 |
| Last Updated: |
February 19, 2012 |
| Study HIC#: |
1112009412 |
| Clinicaltrials.gov ID: |
NCT01307579
|