Response-based Treatment of High-risk Neuroblastoma

Newly Diagnosed High Risk Neuroblastoma Clinical Trial

Official title:

Response-based Treatment of High-risk Neuroblastoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02771743
• Other study ID #: 2015-02-064
• Status: Recruiting
• Phase: Phase 2
• First received: May 12, 2016
• Last updated: May 23, 2016
• Start date: April 2015
• Est. completion date: March 2023

Study information

• Verified date: May 2016
• Source: Samsung Medical Center
• Contact: Ki Woong Sung, MD, PhD
• Phone: 82-2-3410-3529
• Email: kiwoong.sung[@]samsung.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to improve outcome of high risk neuroblastoma by tailoring the treatment intensity of tandem high dose chemotherapy according to the treatment response to induction chemotherapy.

Description:

Although the outcome of high-risk neuroblastoma improved after the introduction of high-dose chemotherapy and autologous stem cell transplantation (HDCT/autoSCT), the outcome still needs to be unsatisfactory.

In the investigator's previous study, good responders who had greater reduction of tumor volume after induction chemotherapy showed lower relapse-free survival compared to poor responders.Simultaneously, the reduction in tumor volume also was greater in patients who died of treatment related mortality than patients who had relapsed tumors. These findings suggest that tailoring treatment intensity according to the early tumor response to induction chemotherapy may improve patient outcomes. So, in this study investigators tailored the treatment intensity of high dose chemotherapy according to the treatment response to induction chemotherapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: March 2023
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with newly diagnosed high risk neuroblastoma

• Patients with informed consent

Exclusion Criteria:

• Patients with progressive disease or relapse

• Patients who underwent high dose chemotherapy before

• Patients with organ dysfunction as follows (creatinine elevation > 3 x upper limit of normal, Total bilirubin > 3 x upper limit of normal, aspartate transaminase/alanine transaminase > 5 x upper limit of normal), ejection fraction <40%

• Pregnant or nursing women

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuroblastoma
• Newly Diagnosed High Risk Neuroblastoma

Intervention

Drug:
• Cisplatin

• Doxorubicin

• Etoposide

• Cyclophosphamide

• Ifosfamide

• Carboplatin

Procedure:
• Tandem HDCT/auto-SCT

Radiation:
• Radiotherapy

Drug:
• Interleukin-2

• Isotretinoin

Radiation:
• MIBG

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of event free survival		Up to 3 years	Yes
Secondary	Rate of late adverse effects		Up to 3 years	Yes