Neuroblastoma Clinical Trial
Official title:
Clinical Study to Evaluate the Efficacy of Prophylactic Itraconazole in High-Dose Chemotherapy and Autologous Hematopoietic Stem Cell Transplantation for Pediatric Solid Tumors
Verified date | November 2008 |
Source | Samsung Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to investigate whether the prophylactic use of itraconazole is a better option than empirical use of itraconazole in the management (prevention and treatment) of fungal infection associated with high-dose chemotherapy and autologous hematopoietic stem cell transplantation in children with high-risk solid tumor.
Status | Completed |
Enrollment | 100 |
Est. completion date | October 2008 |
Est. primary completion date | June 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 15 Years |
Eligibility |
Inclusion Criteria: - Patients with high risk solid tumors who are going to receive high dose chemotherapy and autologous hematopoietic stem cell transplantation Exclusion Criteria: - Significant organ toxicity (National Cancer Institute [NCI] grade > 2) prior to high dose chemotherapy and autologous hematopoietic stem cell transplantation |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Samsung Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Samsung Medical Center |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Presence/absence of documented fungal infection | until post transplant day 30 | No | |
Primary | Presence/absence of clinical fungal infection | until post transplant day 30 | No | |
Primary | Total duration of high fever | until post transplant day 30 | No | |
Primary | Total duration of antibiotic treatment | until post transplant day 30 | No |
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