Pediatric, Cancer Clinical Trial
Official title:
Pharmacokinetics of Itraconazole in Pediatric Cancer Patients
| Verified date | November 2013 |
| Source | Seoul National University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Korea: Food and Drug Administration |
| Study type | Interventional |
This study investigated repeated-dose pharmacokinetics and safety of itraconazole and its active metabolite hydroxyitraconazole in pediatric cancer patients at risk for the development of invasive fungal disease.
| Status | Completed |
| Enrollment | 6 |
| Est. completion date | December 2011 |
| Est. primary completion date | December 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Pediatric patients who are under chemotherapy, and receive itraconazole. Exclusion Criteria: 1. Patients with significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases. - Heart : fractional shortening < 30%, ejection fraction < 45% - Liver : total bilirubin = 2 x upper limit of normal (ULN) ; aminotransferase = 3 x ULN - Kidney : creatinine = 2 x normal or GFR = 60?/min/1.73? 2. Patients with hypersensitivity to azoles. 3. Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study. 4. Pregnant or nursing women. 5. Psychiatric disorder that would preclude compliance. |
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Seoul National University Hospital | Seoul | Chongno-gu |
| Lead Sponsor | Collaborator |
|---|---|
| Seoul National University Hospital |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To investigate repeated-dose pharmacokinetics of itraconazole and its active metabolite hydroxyl itraconazole in pediatric cancer patients | Itraconazole administration 1) Oral for prophylaxis: 2mg/kg/dose,q12hr 2) IV for empirical therapy : After more than 2 days of oral prophylaxis, patients with persistent neutropenic fever / Induction : 5 mg/kg/dose, q12hr X 4 doses / Maintenance : 5 mg/kg/dose,q24hr Sampling 1) During oral : prior to the 5th dose 2) During IV : prior to the every induction and 1-5th maintenance doses, and 1, 2, 4, 8, 12, 24hr after the 3rd IV maintenance Analysis of drug concentrations : Plasma concentrations of itraconazole and hydroxyl-itraconazole are measured using HPLC. |
28 days | No |
| Secondary | To assess empirical antifungal efficacy and safety in pediatric cancer patients | Efficacy evaluation : Treatment is considered successful if all five of the following criteria are met : treatment of baseline fungal infection, absence of breakthrough fungal infection, survival for 7 days after completion, resolution of fever (<38°C for 48hrs) in neutropenia, and no premature discontinuation because of drug related toxicity or lack of efficacy. Safety evaluation : Laboratory are performed at the time of enrollment, twice weekly during therapy, and 1 week after the end of therapy. Drug-related toxicity was graded according to the NCI Common Toxicity Criteria (v4.0). |
28 days | No |