Response-based Treatment of High-risk Neuroblastoma

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02771743

Enrollment

Registered

2016-05-13

Start date

2015-04-30

Completion date

2023-03-31

Last updated

2016-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newly Diagnosed High Risk Neuroblastoma

Keywords

Neuroblastoma, High risk, Tandem high dose chemotherapy

Brief 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.

Detailed 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.

Interventions

DRUGCisplatin

DRUGDoxorubicin

DRUGEtoposide

DRUGCyclophosphamide

DRUGIfosfamide

DRUGCarboplatin

PROCEDURETandem HDCT/auto-SCT

RADIATIONRadiotherapy

DRUGInterleukin-2

DRUGIsotretinoin

RADIATIONMIBG

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Rate of event free survival	Up to 3 years

Secondary

Measure	Time frame
Rate of late adverse effects	Up to 3 years

Countries

South Korea

Contacts

Primary ContactKi Woong Sung, MD, PhD

kiwoong.sung@samsung.com82-2-3410-3529

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026