Efficacy of Prophylactic Itraconazole in High-Dose Chemotherapy and Autologous Hematopoietic Stem Cell Transplantation

NCT00336531 | Completed Phase 4

• 1 other identifier: 2006-02-069
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Neuroblastoma; Brain Tumor; Retinoblastoma; Wilms Tumor; Mycoses

Keywords

prophylactic itraconazole; Relapsed pediatric solid tumors; Embryonal brain tumor

Outcome Measures

Primary Outcomes (4)

• Presence/absence of documented fungal infection

  until post transplant day 30

• Presence/absence of clinical fungal infection

  until post transplant day 30

• Total duration of high fever

  until post transplant day 30

• Total duration of antibiotic treatment

  until post transplant day 30

Interventions

itraconazole DRUG

2.5 mg/kg twice daily for the first two days --\> once daily

Eligibility Criteria

• Age: Up to 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients with high risk solid tumors who are going to receive high dose chemotherapy and autologous hematopoietic stem cell transplantation

You may not qualify if:

• Significant organ toxicity (National Cancer Institute \[NCI\] grade \> 2) prior to high dose chemotherapy and autologous hematopoietic stem cell transplantation

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (1)

• Kim 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 DERIVED

MeSH Terms

Conditions

Neuroblastoma; Brain Neoplasms; Retinoblastoma; Wilms Tumor; Mycoses

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Retinal Neoplasms; Eye Neoplasms; Eye Diseases, Hereditary; Eye Diseases; Retinal Diseases; Neoplasms, Complex and Mixed; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplastic Syndromes, Hereditary; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• KiWoong Sung, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 11, 2006
• First Posted: June 13, 2006
• Study Start: April 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: October 1, 2008
• Last Updated: November 19, 2008

Record last verified: 2008-11

Locations

KR (1)