Clinical trial · Interventional
Efficacy of Prophylactic Itraconazole in High-Dose Chemotherapy and Autologous Hematopoietic Stem Cell Transplantation
Clinical Study to Evaluate the Efficacy of Prophylactic Itraconazole in High-Dose Chemotherapy and Autologous Hematopoietic Stem Cell Transplantation for Pediatric Solid Tumors
NCT00336531CI-TRIAL-00001796completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Mycoses | — | UNRESOLVED | — |
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
| Retinoblastoma | Retinoblastoma | ONTOLOGY_EXACT | 0.98 |
| Wilms Tumor | Wilms Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| itraconazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Presence/absence of documented fungal infection
- timeFrame
- until post transplant day 30
- measure
- Presence/absence of clinical fungal infection
- timeFrame
- until post transplant day 30
- measure
- Total duration of high fever
- timeFrame
- until post transplant day 30
- measure
- Total duration of antibiotic treatment
- timeFrame
- until post transplant day 30
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 15 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKim YJ, Sung KW, Hwang HS, Jung SH, Kim JY, Cho EJ, Lim SJ, Choi YB, Cheuh HW, Lee SH, Yoo KH, Koo HH. Efficacy of itraconazole prophylaxis for autologous stem cell transplantation in children with high-risk solid tumors: a prospective double-blind randomized study. Yonsei Med J. 2011 Mar;52(2):293-300. doi: 10.3349/ymj.2011.52.2.293. PMID 21319349